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 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

Job Title: Senior Executive / Specialist - Case Processing

Employment Type: Contract

Location: Brazil (Remote)

About ClinChoice

ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis.

Our global delivery network has expanded to centers and satellite offices in the United States, Mexico, United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally.

We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision.

 Primary Responsibilities:

Candidate Profile:

• Bachelor’s or Master’s in Pharmacy / Life Sciences or above and in alignment with project / business team requirements.
• Minimum of 3 to 5 years of relevant experience in identified functional domain/ business workstream.
• Must have hands on experience with MS office applications (Outlook, Excel, Word, Power Point etc.).
• Must be able to Write and speak Japanese.
• Dynamic working hours.

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 an Area/Local Safety Officer Consultant for 12 months Contract with possibility of extension to join one of our clients.

The Area Safety Officer is responsible for ensuring that the local operating company (LOC) Safety activities related to all products are managed in compliance with local regulations and company policies/procedures at a local, regional, and global levels and in accordance with any product vigilance agreements with third party business partners.

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.  

Main Job Tasks and Responsibilities:

Safety and PV System Management

• Perform the quality check of the PV cases and ensure that the English translation has been properly performed.
• Keep up to date a local tracker of the individual safety reports.
• Be the subject matter expert at local level on the case management activities.
• Closely follow the respect of the regulatory timelines of the submission of the safety reports to the local health authorities and communicate any potential delay to the appropriate teams.
• Establish and maintain local indicators on the compliance of the safety reports submission.
• Oversee the training of the local employees and the business partners. Maintain KPI and present them during regular team meetings.
• Perform regulatory monitoring for impact on vigilance activities and responsibilities.
• Perform reconciliation with other departments (distributors, third parties, vendors, and internal stakeholders).
• Maintain oversight of proper identification of local literature articles for AE reporting as required.
• Perform reporting/ submissions of safety reports/ updates/information (e.g., SAE, SUE, SUSARs, PSUR, RMP) to local health authorities and other Client departments as applicable.
• Supporting Area Safety Lead in notifying local health authorities of any safety issues including SSI/ESI and Signals.
• Maintain up-to-date knowledge of local requirements for pharmacovigilance, cosmetic and device vigilances including reporting requirements (for all applicable product classes in the territory) and collaborating with the global team to implement process changes required for identification of new requirements.
• Record self-identified non-conformances and collaborating with the global team to investigate non-conformances while developing and implementing effective CAPAs.
• Perform other agreed tasks assigned by manager
• Perform document management and archiving as required

Procedural Document

• Ensure current knowledge of all relevant company procedures and training.
• Develop, update, and implement local procedures to ensure compliance with Clients global procedures and national requirements.

Audit & Inspection readiness

Support in local health authority inspections and audits conducted locally, including responding to queries during the conduct and collaborating with the global team to develop and implement CAPA (Corrective and Preventative Action) plans as applicable

PV contract management

Provide PV clauses to be included within local agreements and contribute to the PSMF with contracts-related information

Business Continuity

Ensure implementation of local business continuity plans (e.g., inspection readiness, AE reporting coverage)

Education and Experience:

Education: health care science professional or equivalent training

• Significant training in data management with strong IT skills.
• 2-4 years of relevant experience (e.g. case data management, reconciliation manager, vigilance IT project manager…).
• Fluent in English. French as a mother tongue.
• Excellent communication skills and ability to work with cross-functional teams.
• Rigor is a key skill for this mission.

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 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: Area Safety Officer, Local Safety Officer, PV, QC, CAPA,QPPV

#LI-PB1

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

Job Description

Job Title: Medical Reviewer

Employment Type: Contract

Location: Brazil

Experience – 2 to 5 Years

About ClinChoice

ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis.

Our global delivery network has expanded to centres and satellite offices in the United States, Mexico, United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally.

We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision.

Primary Responsibilities:

• Awareness and understanding of relevant GVP modules.
• Perform medical review of non-serious & serious ICSRs with emphasis on seriousness, expectedness, causality & narrative etc. without missing on quality & compliance.
• Experience of medical review of ICSRs received from sources such as Spontaneous, Literature, Regulatory Authority, Solicited and Clinical trials.
• Experience across multiple therapeutic areas such as Oncology, Respiratory, Immunology, Neuroscience, Rare diseases etc.
• Support triage of cases and determine seriousness and relatedness across products as assigned.
• Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labelling and review narrative.
• Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas.
• Involve in process improvement activities such as implementation of quality control process.
• Provide medical guidance and expert opinion on the cases to the data entry associates and quality reviewers to help resolve queries.
• Identify and resolve case issues, coordinate with client therapeutic teams and within functional team and manage as appropriate.
• Maintain PV expertise, and understanding of international safety regulations and guidelines.
• Responsible for completing the MR activities in the safety database within the stipulated time to comply with service level agreements and regulatory timelines.
• Provide timely feedback to case processors on the errors/ discrepancies noted.
• Assist in training/mentoring of other case processing/medical review personnel as necessitated.
• Adapt to different client case processing conventions and multi-task as per business needs.
• Perform ad-hoc tasks as advised by the team lead/manager with quality and compliance as per project requirement.
• Participate in organizational activities to meet objectives suitable for the role/area of expertise.

Candidate Profile:

• Should be a MBBS/MD with at least 2 years of experience as Medical Reviewer for ICSRs.
• Must possess thorough knowledge of ICH-GCP, relevant GVP module, 21 CFR guidelines and other regulatory requirements.
• Training and mentoring skill (GVP concepts & medical aspects such as disease condition, product portfolio etc)
• Must have hands on experience with MS Office applications (Outlook, Excel, Word, Power Point etc)

• Must be able to Write and speak Japanese.
• Dynamic working hours.