Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for Analyst Regulatory Affairs Consultant with Hybrid option for 12 months CONTRACT and renewable, to join one of our major consumer products clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. 

Position Summary

Ensures proper submission and approvals for market licenses including new registrations, changes and timely renewals, and establishment registrations, organizing and balancing a multitude of projects simultaneously.

• Elaborate regulatory strategy and execute submission of changes, new registrations and renewals in timely manner with some guidance.
• Execute activities to obtain or update establishment registration licenses.
• Execute post-approval activities such as preparation of communications to stakeholders, labels and Instructions for Use and system updates.
• Request and follow-up of documentation to prepare registration dossiers.
• Supports regional team on product submissions schedules, prioritization, and pipeline management.
• Support internal and external audits with documentation requests.
• Interacts with other JJ stakeholders, government agencies in a professional, decisive, & articulate manner.
• Act as a point of contact for stakeholders to support business plans and regulatory needs.
• Review labels compliance in internal system.

• Support projects as representative of the subject/country.
• Elaborate procedures of the area.
• Organize team meetings and elaborate agenda and minutes.
• Manage quality issues.
• Manage compulsory certification (INMETRO) and GMP activities.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.  The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Regulatory Affairs, Consultant

#LI-PB1 #LI-Hybrid #Contract

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a CMC Strategist Consultant with Remote option in CANADA for 12 months CONTRACT and renewable, to join one of our major consumer products clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. 

Position Summary

We are seeking a Regulatory Strategist – CMC to support global regulatory strategy and execution across the product lifecycle. This role will be responsible for developing and implementing CMC regulatory strategies, preparing and reviewing high-quality regulatory submissions, and supporting post-approval activities for U.S. FDA and Health Canada. The ideal candidate brings strong technical CMC knowledge, hands-on submission experience, and the ability to partner cross-functionally with CMC, Quality, and Manufacturing teams.

Key Responsibilities

Regulatory Strategy & Planning
•    Develop and execute CMC regulatory strategies for new product development and product lifecycle management.
•    Support regulatory strategy planning and act as a key contributor to dossier planning for global submissions.
•    Provide regulatory input on CMC development activities, change management, and post-approval strategies.
Regulatory Submissions (U.S. FDA & Health Canada)
•    Support preparation and submission of CMC regulatory documents for new product filings to US FDA and Health Canada.
•    Compile, review, and manage Modules 1, 2, and 3 of U.S. regulatory dossiers.
•    Review CMC documentation and perform DMF assessments, including coordination with DMF holders as needed.
Post-Approval Activities
•    Manage post-approval submissions to US FDA, including:
o    Major and Moderate CMC amendments
o    Administrative amendments
o    DMF amendments
o    Annual Reports
•    Lead and coordinate timely responses to FDA Information Requests (IRs) and Complete Response Letters (CRLs).
•    Support post-approval submissions to Health Canada, including compilation and submission of Annual Notifications and Supplements.
Change Control & Compliance
•    Assess and manage Global Change Controls (GCCs) to determine regulatory impact and required filings.
•    Support preparation and review of Annual Product Reports (APRs).
•    Ensure compliance with applicable regulatory guidelines, policies, and global CMC requirements.

Required Qualifications

•    Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biotechnology, or a related discipline (advanced degree preferred).
•    3+ years of experience in CMC regulatory affairs within pharmaceutical, biotech, or CDMO environments.
•    Hands-on experience with U.S. FDA and Health Canada CMC submissions across the product lifecycle.
•    Strong working knowledge of ICH guidelines, FDA regulations, and Health Canada requirements.
•    Experience compiling and reviewing Modules 1–3 and working with Drug Master Files (DMFs).
•    Proven ability to manage multiple submissions and timelines in a fast-paced environment.

Preferred Skills & Competencies

•    Strong analytical and problem-solving skills.
•    Excellent written and verbal communication abilities.
•    Ability to work cross-functionally and influence stakeholders.
•    High attention to detail with a quality- and compliance-focused mindset.
•    Experience with global regulatory strategies beyond North America is a plus.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.  The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Regulatory CMC. 

#LI-PB1 #LI-Remote #Contract

AI: 

Our hiring process includes AI screening for keywords and minimum qualifications. Recruiters review all results. 

Vacancy: 

This posting is for an existing vacancy. 

Open Date: 4/24/2026

Close Date: 6/8/2026

The following disclaimer for CA must be included (remove the equal opportunities wording from the advert template in the bottom paragraph and replace with the following & delete these instructions):

ClinChoice Canada Inc. is proud to be an equal opportunity employer, valuing and respecting diversity.  We are committed to inclusive, barrier-free recruitment and selection processes. We will accommodate the needs of qualified applicants under the Human Rights Code and the Accessibility for Ontarians Disabilities Act, in all aspects of the hiring process, upon request by calling + 1 (647)724-5709 x 301. 

We thank all applicants for their interest; however, only those being considered for an interview will be contacted. In accordance with Federal Personal Information Protection and Electronic Documents Act ("PIPEDA") , personal information is collected under the authority of the Act and will only be used for candidate selection.

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Regulatory Affairs Associate Consultant for 12 months Contract with possibility of extension to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.  

re you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Regulatory Affairs Associate Consultant for 12 months Contract with possibility of extension to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.  

Regulatory Affairs Jr. Specialist Consultant / Especialista Jr. de Asuntos Regulatorios

Location / Ubicación: Ciudad de México, México

Position Summary / Resumen del puesto:

Support the preparation, review and follow-up of regulatory submissions for medical devices, ensuring compliance with applicable regulations before health authorities such as COFEPRIS, enabling timely approvals and maintenance of product registrations.

Apoyar en la preparación, revisión y seguimiento de trámites regulatorios para dispositivos médicos, asegurando el cumplimiento de la normativa aplicable ante la autoridad sanitaria COFEPRIS, facilitando la obtención y mantenimiento de los registros sanitarios.

Key responsabilities / Responsabilidades principales:

• Prepare and compile regulatory documentation for COFEPRIS submissions (registrations, renewals, changes).
• Follow up on submissions with regulatory authority (COFEPRIS).
• Support interpretation of local and international regulations.
• Support coordination of requests and activities with cross-functional teams.
• Maintain updated regulatory files and databases.

• Preparar y compilar documentación regulatoria para sometimientos ante COFEPRIS (registros, renovaciones, modificaciones).
• Dar seguimiento a los trámites ante autoridad regulatoria (COFEPRIS).
• Apoyar en la interpretación de normativas locales e internacionales.
• Apoyar la coordinación de solicitudes y actividades con áreas internas.
• Mantener actualizados archivos regulatorios y bases de datos.

Qualifications / Requisitos:

Bachelor’s degree in Chemistry, Pharmaceutical Chemistry, Pharmacy, Biomedical Engineering, Biotechnology, or related field.

Licenciatura en Química, QFB, QFI, QBP, Farmacia, Ingeniería Biomédica, Biotecnología o afín.

Experience / Experiencia:

Minimum 1 year of experience in regulatory affairs, quality or medical device industry.

Technical skills / Conocimientos técnicos:

• Mexican medical device regulations (COFEPRIS).
• Medical device classification.
• NOMs and standards aplicable.
• Intermediate-advanced English (technical reading required).
• Intermediate Excel skills (data tracking, pivot tables, basic formulas, reporting).

Core competencies / competencias clave:

• Attention to detail.
• Organizational and documentation skills.
• Effective communication.
• Team collaboration
• Learning Agility.

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Regulatory Affairs Associate Consultant for 12 months Contract with possibility of extension to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.  

JOB DESCRIPTION

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Sr. Regulatory Affairs Specialist Consultant for 12 months Contract with possibility of extension to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.  

The Regulatory Affairs Specialist I is responsible for providing operational and administrative support to Regulatory Affairs activities for the Medical Devices portfolio in Colombia. Under guidance from more senior Regulatory Affairs professionals, this role supports regulatory documentation management, systems updates, and project coordination to ensure compliance with applicable regulations and Clients internal requirements.

Key Responsibilities

• Support collection and tracking of regulatory documentation for INVIMA submissions.
• Perform initial completeness checks of regulatory documentation.
• Maintain organized and audit-ready regulatory files.
• Assist with execution of approved regulatory plans under supervision.

• Update regulatory systems, databases, and trackers.

  • Support coordination of regulatory projects and cross-functional requests.
  • Ensure compliance with company policies and procedures.

  Qualifications

  Bachelor’s degree in Life Sciences, Engineering, Pharmacy, or related field.
• Entry-level role; prior internships or exposure to regulated environments is a plus.
• Basic understanding of Colombian medical device regulations (Decree 4725 of 2005).

• Proficiency in Microsoft Office tools.
    Manejo de herramientas Microsoft Office.

  • Strong attention to detail and willingness to learn.
    Alta atención al detalle y disposición para aprender.

  Core Competencies & Behaviors / Competencias y Comportamientos Clave

  • Learning agility and curiosity.
    Agilidad de aprendizaje y curiosidad.
  • Attention to detail.
    Atención al detalle.
  • Accountability for assigned tasks.
    Responsabilidad sobre las tareas asignadas.
  • Collaboration with cross-functional teams.
    Colaboración con equipos multifuncionales.
  • Proactive communication.
    Comunicación proactiva.

  Other Information / Información Adicional

  This role requires responsible handling of confidential and regulated information and is performed under supervision in alignment with established regulatory procedures.

  Este cargo requiere el manejo responsable de información confidencial y regulada y se desempeña bajo supervisión, de acuerdo con los procedimientos regulatorios establecidos.

Key Words: Regulatory Affairs, data analysis, EU MDD, EU MDR

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Labeling Artwork Controller - Consultant in Poland for 12 months Contract with REMOTE option with possibility of extension to join one of our consumer product clients.

Role Summary

The Regional / Senior Artwork Controller is responsible for managing the end-to-end artwork development process (brief → final release) for packaging and labeling components within the region. This role ensures timely delivery of high-quality, compliant artwork by coordinating cross-functional teams and external vendors, while driving process improvements and maintaining operational excellence. This role combines hands-on execution with team supervision.

Key Responsibilities:

• Manage the end-to-end artwork development process from initiation through approval and release, ensuring timely delivery of high-quality labeling components. 
• Act as the primary liaison between PMO, Regulatory Affairs, Marketing, Packaging, Quality, Supply Chain, and external vendors/agencies. 
• Validate briefs for accuracy and completeness; collaborate with cross-functional teams to resolve discrepancies. 
• Oversee timelines, resource planning, and progress tracking for multiple concurrent labeling projects. 
• Coordinate review and approval of labeling content and artwork in internal systems, ensuring compliance with regulatory, legal, and corporate standards. 
• Drive process improvements related to artwork development, approval workflows, and digital tools. 
• Investigate Root Cause Analyses (RCAs) and implement Corrective and Preventive Actions (CAPA) as needed. 
• Maintain artwork issue logs and attend escalation meetings to provide updates. 
• Identify inefficiencies and escalate to Hub Leads when required. 
• Participate in content lock meetings to ensure stakeholder alignment. 
• Manage Veraciti system-related issues and escalate appropriately. 
• Suggest and implement technology solutions for artwork and labeling processes. 
• Create, update, and maintain training documentation for systems and processes. 
• Supervise Artwork Controllers to ensure task completion and provide support during peak periods. 
• Onboard new hires on artwork management systems and end-to-end processes; conduct quarterly refreshers on best practices. 
• Provide guidance on escalation channels and support SMEs, Artwork Process Leads, Vendors, and Hub Leads with artwork production deployment. 
• Track and follow up on action items from cross-functional meetings. 
• Communicate project status, risks, and milestones consistently to stakeholders. 
• Attend regional project meetings (Kick-off, Overview, Alignment, Technical with Printer) and provide updates. 
• Share project insights for dashboards and analytics; contribute to KPI reviews and compliance initiatives. 
• Gather requirements for new regional jobs and assess resources requirements and provide job quotations when required. 
• Conduct design-to-press color management assessments and feasibility consultations. 
• Monitor and maintain regional project timelines and costs; anticipate and resolve roadblocks. 
• Address process and executional quality issues; support system and process improvements. 
• Manage ad-hoc artwork-related requests and cascade process/system communications.

Qualifications & Experience:

• Bachelor’s degree in Life Sciences, Business, Packaging Technology, or related field; 
• 10+ years in labeling design, proofreading, coordination, regulatory, packaging, and project management within consumer health, pharmaceutical, or medical device industries. 
• Strong knowledge of global regulatory requirements for product labeling and packaging. 
• Proven ability to manage multiple projects and cross-functional teams in a deadline-driven environment. 
• Hands-on experience with PLM and electronic artwork systems (e.g., Agile, GLAMS, Loftware, Veraciti, Veeva). 
• Expertise in Adobe Creative Suite (Illustrator, InDesign, Photoshop, Acrobat Pro). 
• Familiarity with pre-press and print processes (CMYK, Pantone, dielines, bleed, etc.). 
• Skilled in proofreading tools (e.g., TVT, GlobalVision, InformCC) and regulatory content validation. 
• Six Sigma Green Belt certification or equivalent experience in continuous improvement. 
• Excellent communication, problem-solving, and organizational skills. 
• PMP certification or formal project management training is a plus.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Keywords: Regulatory Affairs, Labeling, Artwork, packaging, consumer products

#LI-PR1 #LI-REMOTE #Manager #Contract

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Labeling Artwork Controller - Consultant in Czech Republic for 12 months Contract with REMOTE option with possibility of extension to join one of our consumer product clients.

Role Summary

The Regional / Senior Artwork Controller is responsible for managing the end-to-end artwork development process (brief → final release) for packaging and labeling components within the region. This role ensures timely delivery of high-quality, compliant artwork by coordinating cross-functional teams and external vendors, while driving process improvements and maintaining operational excellence. This role combines hands-on execution with team supervision.

Key Responsibilities:

• Manage the end-to-end artwork development process from initiation through approval and release, ensuring timely delivery of high-quality labeling components. 
• Act as the primary liaison between PMO, Regulatory Affairs, Marketing, Packaging, Quality, Supply Chain, and external vendors/agencies. 
• Validate briefs for accuracy and completeness; collaborate with cross-functional teams to resolve discrepancies. 
• Oversee timelines, resource planning, and progress tracking for multiple concurrent labeling projects. 
• Coordinate review and approval of labeling content and artwork in internal systems, ensuring compliance with regulatory, legal, and corporate standards. 
• Drive process improvements related to artwork development, approval workflows, and digital tools. 
• Investigate Root Cause Analyses (RCAs) and implement Corrective and Preventive Actions (CAPA) as needed. 
• Maintain artwork issue logs and attend escalation meetings to provide updates. 
• Identify inefficiencies and escalate to Hub Leads when required. 
• Participate in content lock meetings to ensure stakeholder alignment. 
• Manage Veraciti system-related issues and escalate appropriately. 
• Suggest and implement technology solutions for artwork and labeling processes. 
• Create, update, and maintain training documentation for systems and processes. 
• Supervise Artwork Controllers to ensure task completion and provide support during peak periods. 
• Onboard new hires on artwork management systems and end-to-end processes; conduct quarterly refreshers on best practices. 
• Provide guidance on escalation channels and support SMEs, Artwork Process Leads, Vendors, and Hub Leads with artwork production deployment. 
• Track and follow up on action items from cross-functional meetings. 
• Communicate project status, risks, and milestones consistently to stakeholders. 
• Attend regional project meetings (Kick-off, Overview, Alignment, Technical with Printer) and provide updates. 
• Share project insights for dashboards and analytics; contribute to KPI reviews and compliance initiatives. 
• Gather requirements for new regional jobs and assess resources requirements and provide job quotations when required. 
• Conduct design-to-press color management assessments and feasibility consultations. 
• Monitor and maintain regional project timelines and costs; anticipate and resolve roadblocks. 
• Address process and executional quality issues; support system and process improvements. 
• Manage ad-hoc artwork-related requests and cascade process/system communications.

Qualifications & Experience:

• Bachelor’s degree in Life Sciences, Business, Packaging Technology, or related field; 
• 10+ years in labeling design, proofreading, coordination, regulatory, packaging, and project management within consumer health, pharmaceutical, or medical device industries. 
• Strong knowledge of global regulatory requirements for product labeling and packaging. 
• Proven ability to manage multiple projects and cross-functional teams in a deadline-driven environment. 
• Hands-on experience with PLM and electronic artwork systems (e.g., Agile, GLAMS, Loftware, Veraciti, Veeva). 
• Expertise in Adobe Creative Suite (Illustrator, InDesign, Photoshop, Acrobat Pro). 
• Familiarity with pre-press and print processes (CMYK, Pantone, dielines, bleed, etc.). 
• Skilled in proofreading tools (e.g., TVT, GlobalVision, InformCC) and regulatory content validation. 
• Six Sigma Green Belt certification or equivalent experience in continuous improvement. 
• Excellent communication, problem-solving, and organizational skills. 
• PMP certification or formal project management training is a plus.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Keywords: Regulatory Affairs, Labeling, Artwork, packaging, consumer products

#LI-PR1 #LI-REMOTE #Manager #Contract

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Labeling Artwork Controller - Consultant in Italy for 12 months Contract with REMOTE option with possibility of extension to join one of our consumer product clients.

Role Summary

The Regional / Senior Artwork Controller is responsible for managing the end-to-end artwork development process (brief → final release) for packaging and labeling components within the region. This role ensures timely delivery of high-quality, compliant artwork by coordinating cross-functional teams and external vendors, while driving process improvements and maintaining operational excellence. This role combines hands-on execution with team supervision.

Key Responsibilities:

• Manage the end-to-end artwork development process from initiation through approval and release, ensuring timely delivery of high-quality labeling components. 
• Act as the primary liaison between PMO, Regulatory Affairs, Marketing, Packaging, Quality, Supply Chain, and external vendors/agencies. 
• Validate briefs for accuracy and completeness; collaborate with cross-functional teams to resolve discrepancies. 
• Oversee timelines, resource planning, and progress tracking for multiple concurrent labeling projects. 
• Coordinate review and approval of labeling content and artwork in internal systems, ensuring compliance with regulatory, legal, and corporate standards. 
• Drive process improvements related to artwork development, approval workflows, and digital tools. 
• Investigate Root Cause Analyses (RCAs) and implement Corrective and Preventive Actions (CAPA) as needed. 
• Maintain artwork issue logs and attend escalation meetings to provide updates. 
• Identify inefficiencies and escalate to Hub Leads when required. 
• Participate in content lock meetings to ensure stakeholder alignment. 
• Manage Veraciti system-related issues and escalate appropriately. 
• Suggest and implement technology solutions for artwork and labeling processes. 
• Create, update, and maintain training documentation for systems and processes. 
• Supervise Artwork Controllers to ensure task completion and provide support during peak periods. 
• Onboard new hires on artwork management systems and end-to-end processes; conduct quarterly refreshers on best practices. 
• Provide guidance on escalation channels and support SMEs, Artwork Process Leads, Vendors, and Hub Leads with artwork production deployment. 
• Track and follow up on action items from cross-functional meetings. 
• Communicate project status, risks, and milestones consistently to stakeholders. 
• Attend regional project meetings (Kick-off, Overview, Alignment, Technical with Printer) and provide updates. 
• Share project insights for dashboards and analytics; contribute to KPI reviews and compliance initiatives. 
• Gather requirements for new regional jobs and assess resources requirements and provide job quotations when required. 
• Conduct design-to-press color management assessments and feasibility consultations. 
• Monitor and maintain regional project timelines and costs; anticipate and resolve roadblocks. 
• Address process and executional quality issues; support system and process improvements. 
• Manage ad-hoc artwork-related requests and cascade process/system communications.

Qualifications & Experience:

• Bachelor’s degree in Life Sciences, Business, Packaging Technology, or related field; 
• 10+ years in labeling design, proofreading, coordination, regulatory, packaging, and project management within consumer health, pharmaceutical, or medical device industries. 
• Strong knowledge of global regulatory requirements for product labeling and packaging. 
• Proven ability to manage multiple projects and cross-functional teams in a deadline-driven environment. 
• Hands-on experience with PLM and electronic artwork systems (e.g., Agile, GLAMS, Loftware, Veraciti, Veeva). 
• Expertise in Adobe Creative Suite (Illustrator, InDesign, Photoshop, Acrobat Pro). 
• Familiarity with pre-press and print processes (CMYK, Pantone, dielines, bleed, etc.). 
• Skilled in proofreading tools (e.g., TVT, GlobalVision, InformCC) and regulatory content validation. 
• Six Sigma Green Belt certification or equivalent experience in continuous improvement. 
• Excellent communication, problem-solving, and organizational skills. 
• PMP certification or formal project management training is a plus.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Keywords: Regulatory Affairs, Labeling, Artwork, packaging, consumer products

#LI-PR1 #LI-REMOTE #Manager #Contract

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as an Associate, Regulatory Affairs on a permanent basis. 

Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career!

Main Job Tasks and Responsibilities: 

• Support with new application for marketing authorization/renewal/variation of medicinal products, medical devices, cosmetics, food supplements for regulatory submission and follow-up closely on queries from HA through to approval
• Publishing and submission of products registration applications
• Coordination of activities ensuring product registration information is accurate and current
• Support compilation, tracking, indexing and archival of regulatory information
• Specifying storage, labelling and packaging requirements for regulated products
• Creation, update, review and quality check of product labels

Education and Experience:

• Bachelor’s Degree in Life Science (Chemistry, Biology, Biomedical Engineering)
• Experience in the related field is a plus
• Fluency in English
• Ability to work under pressure to meet the deadlines
• Ability to get a challenge and perform excellent teamwork

Our Benefits: 

• Flexible Working Hours
• Full performance and development process with end of year reviews
• Team events and end of year party
• Employee satisfaction survey - your feedback is important for continuous improvement
• Health Insurance

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. 

Who will you be working for?

About ClinChoice  
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!

Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.  The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Labeling Artwork Controller Consultant for 12 months Contract with possibility of extension to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.  

Job Description

Artwork Controller

Role Summary

The Regional / Senior Artwork Controller is responsible for managing the end-to-end artwork development process (brief → final release) for packaging and labeling components within the region. This role ensures timely delivery of high-quality, compliant artwork by coordinating cross-functional teams and external vendors, while driving process improvements and maintaining operational excellence. This role combines hands-on execution with team supervision.

Key Responsibilities:

• Manage the end-to-end artwork development process from initiation through approval and release, ensuring timely delivery of high-quality labeling components.
• Act as the primary liaison between PMO, Regulatory Affairs, Marketing, Packaging, Quality, Supply Chain, and external vendors/agencies.
• Validate briefs for accuracy and completeness; collaborate with cross-functional teams to resolve discrepancies.
• Oversee timelines, resource planning, and progress tracking for multiple concurrent labeling projects.
• Coordinate review and approval of labeling content and artwork in internal systems, ensuring compliance with regulatory, legal, and corporate standards.
• Drive process improvements related to artwork development, approval workflows, and digital tools.
• Investigate Root Cause Analyses (RCAs) and implement Corrective and Preventive Actions (CAPA) as needed.
• Maintain artwork issue logs and attend escalation meetings to provide updates.
• Identify inefficiencies and escalate to Hub Leads when required.
• Participate in content lock meetings to ensure stakeholder alignment.
• Manage Veraciti system-related issues and escalate appropriately.
• Suggest and implement technology solutions for artwork and labeling processes.
• Create, update, and maintain training documentation for systems and processes.
• Supervise Artwork Controllers to ensure task completion and provide support during peak periods.
• Onboard new hires on artwork management systems and end-to-end processes; conduct quarterly refreshers on best practices.
• Provide guidance on escalation channels and support SMEs, Artwork Process Leads, Vendors, and Hub Leads with artwork production deployment.
• Track and follow up on action items from cross-functional meetings.
• Communicate project status, risks, and milestones consistently to stakeholders.
• Attend regional project meetings (Kick-off, Overview, Alignment, Technical with Printer) and provide updates.
• Share project insights for dashboards and analytics; contribute to KPI reviews and compliance initiatives.
• Gather requirements for new regional jobs and assess resources requirements and provide job quotations when required.
• Conduct design-to-press color management assessments and feasibility consultations.
• Monitor and maintain regional project timelines and costs; anticipate and resolve roadblocks.
• Address process and executional quality issues; support system and process improvements.
• Manage ad-hoc artwork-related requests and cascade process/system communications.

Qualifications & Experience:

• Bachelor’s degree in Life Sciences, Business, Packaging Technology, or related field;
• 10+ years in labeling design, proofreading, coordination, regulatory, packaging, and project management within consumer health, pharmaceutical, or medical device industries.
• Strong knowledge of global regulatory requirements for product labeling and packaging.
• Proven ability to manage multiple projects and cross-functional teams in a deadline-driven environment.
• Hands-on experience with PLM and electronic artwork systems (e.g., Agile, GLAMS, Loftware, Veraciti, Veeva).
• Expertise in Adobe Creative Suite (Illustrator, InDesign, Photoshop, Acrobat Pro).
• Familiarity with pre-press and print processes (CMYK, Pantone, dielines, bleed, etc.).
• Skilled in proofreading tools (e.g., TVT, GlobalVision, InformCC) and regulatory content validation.
• Six Sigma Green Belt certification or equivalent experience in continuous improvement.
• Excellent communication, problem-solving, and organizational skills.
• PMP certification or formal project management training is a plus.

Key Words: Regulatory Affairs, Artwork, Labeling design, proofreading

#LI-PB1 #LI-REMOTE

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Labeling Artwork Controller - Consultant in High Wycombe, UK for 12 months Contract with possibility of extension to join one of our consumer product clients.

Role Summary

The Regional / Senior Artwork Controller is responsible for managing the end-to-end artwork development process (brief → final release) for packaging and labeling components within the region. This role ensures timely delivery of high-quality, compliant artwork by coordinating cross-functional teams and external vendors, while driving process improvements and maintaining operational excellence. This role combines hands-on execution with team supervision.

Key Responsibilities:

• Manage the end-to-end artwork development process from initiation through approval and release, ensuring timely delivery of high-quality labeling components. 
• Act as the primary liaison between PMO, Regulatory Affairs, Marketing, Packaging, Quality, Supply Chain, and external vendors/agencies. 
• Validate briefs for accuracy and completeness; collaborate with cross-functional teams to resolve discrepancies. 
• Oversee timelines, resource planning, and progress tracking for multiple concurrent labeling projects. 
• Coordinate review and approval of labeling content and artwork in internal systems, ensuring compliance with regulatory, legal, and corporate standards. 
• Drive process improvements related to artwork development, approval workflows, and digital tools. 
• Investigate Root Cause Analyses (RCAs) and implement Corrective and Preventive Actions (CAPA) as needed. 
• Maintain artwork issue logs and attend escalation meetings to provide updates. 
• Identify inefficiencies and escalate to Hub Leads when required. 
• Participate in content lock meetings to ensure stakeholder alignment. 
• Manage Veraciti system-related issues and escalate appropriately. 
• Suggest and implement technology solutions for artwork and labeling processes. 
• Create, update, and maintain training documentation for systems and processes. 
• Supervise Artwork Controllers to ensure task completion and provide support during peak periods. 
• Onboard new hires on artwork management systems and end-to-end processes; conduct quarterly refreshers on best practices. 
• Provide guidance on escalation channels and support SMEs, Artwork Process Leads, Vendors, and Hub Leads with artwork production deployment. 
• Track and follow up on action items from cross-functional meetings. 
• Communicate project status, risks, and milestones consistently to stakeholders. 
• Attend regional project meetings (Kick-off, Overview, Alignment, Technical with Printer) and provide updates. 
• Share project insights for dashboards and analytics; contribute to KPI reviews and compliance initiatives. 
• Gather requirements for new regional jobs and assess resources requirements and provide job quotations when required. 
• Conduct design-to-press color management assessments and feasibility consultations. 
• Monitor and maintain regional project timelines and costs; anticipate and resolve roadblocks. 
• Address process and executional quality issues; support system and process improvements. 
• Manage ad-hoc artwork-related requests and cascade process/system communications.

Qualifications & Experience:

• Bachelor’s degree in Life Sciences, Business, Packaging Technology, or related field; 
• 10+ years in labeling design, proofreading, coordination, regulatory, packaging, and project management within consumer health, pharmaceutical, or medical device industries. 
• Strong knowledge of global regulatory requirements for product labeling and packaging. 
• Proven ability to manage multiple projects and cross-functional teams in a deadline-driven environment. 
• Hands-on experience with PLM and electronic artwork systems (e.g., Agile, GLAMS, Loftware, Veraciti, Veeva). 
• Expertise in Adobe Creative Suite (Illustrator, InDesign, Photoshop, Acrobat Pro). 
• Familiarity with pre-press and print processes (CMYK, Pantone, dielines, bleed, etc.). 
• Skilled in proofreading tools (e.g., TVT, GlobalVision, InformCC) and regulatory content validation. 
• Six Sigma Green Belt certification or equivalent experience in continuous improvement. 
• Excellent communication, problem-solving, and organizational skills. 
• PMP certification or formal project management training is a plus.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Keywords: Regulatory Affairs, Labeling, Artwork, packaging, consumer products

#LI-PR1 #LI-HYBRID #Manager #Contract