Role and Responsibilities

Role: Responsible for development and implementation of new and revised pharmaceutical drug product labeling for both pipeline and commercial products across global market (including FDA, EMA, Health Canada, GCC, APAC, LATAM, and other emerging regions) ensuring compliance with applicable regulations, guidelines, and company standards.

Key Responsibilities

• Oversee regulatory labeling activities across the entire product lifecycle from development through post-approval, ensuring timely submissions and adherence to international health authority requirements.
• Act as a subject matter expert for global labeling regulations, standards and best practices.

 Responsibilities: 

• Initiate and monitor the process for new and revised labeling requests according to internal procedures.
• Prepare and update labeling components such as SmPC, PIL, USPI, carton/container labels, and electronic formats (e.g., SPL, XML) for global submissions.
• Ensure regulatory compliance, accuracy, and version control of all new and revised labeling.
• Coordinate, monitor, and expedite labeling changes to meet established deadlines for HA submission and/or production schedules.
• Coordinating with artworks preparations team for development of label / cartons / package insert for submission purposes.
• Initiate and approve change controls for new and revised labeling.
• Participate in Azurity’s Labeling Management Review Committee (LMRC) weekly meetings to finalize and approve labeling.
• Develop collaborative and respectful relationships with internal and external customers, including but not limited to, Packaging Operations, Marketing, Medical Affairs, Regulatory Affairs, Supply Chain, and artwork and print vendors to develop labeling.
• Monitor and update the labeling tracker to ensure timely progress and adherence to project timelines.
• Monitor global regulatory changes, guidance documents, and safety updates that impact product labeling.
• Archive controlled label copies and master label files according to internal procedures.

Required Skills and Experience

• Ability to read, understand, and follow HA regulations and guidance documents related to labeling.
• Proven experience collaborating within cross-functional teams to achieve shared objectives.
• Strong attention to detail and ability to meet deadlines
• Highly skilled at prioritizing and managing multiple tasks simultaneously.
• Strong interpersonal skills and an effective communicator (phone, email, web-ex, video, in person)
• Strong sense of teamwork, ability to build collaborative relationships.
• Adept at identifying, addressing, and escalating issues promptly to ensure resolution.
• Familiar with Regulatory Information Management (RIM) systems like Veeva Vault and/or similar platforms.
• Ability to work with large datasets and detailed documentation.

Preferred Qualifications

• 8-12 years of pharmaceutical labeling experience.
• Bachelor’s/ Master’s degree in scientific discipline preferred.

About the Role

The Manager of Medical Information is a key member of the Medical Affairs team who leverages therapeutic and product knowledge to oversee internal and external communication on Azurity products, including the management of unsolicited medical information requests from health care providers (HCPs) and other external stakeholders. This person will provide medical/scientific input to cross-functional teams and will also be responsible for contributing to creating reports and various scientific communications. It is expected that this candidate will develop strong expertise in Azurity’s relevant therapeutic areas.

 Key Responsibilities

• Provide clinical and technical product knowledge in response to clinical/medical inquiries from external and internal customers
• Respond with a sense of urgency and ensure accurate, timely, and appropriate verbal and written responses to unsolicited medical information inquiries from HCPs, payers and managed healthcare organizations, which are not covered by existing responses
• Help support the MI team with providing guidance to the Medical Information Call Center, including but not limited to, helping with escalated cases and providing on-going training/coaching to ensure excellent customer service by the call center staff
• Develop and maintain a product knowledge database, including standard response letters (SRLs) and “frequently asked questions” (FAQ) documents by utilizing the highest level of scientific data so that HCPs can make informed and educated clinical decisions about Azurity’s products
• Analyze reports and metrics to identify trends, insights and knowledge gaps and provide quarterly updates to internal stakeholders
• Review new and relevant data so that content is updated proactively resulting in the most current information in medical information resources for Medical Affairs colleagues and call center staff to share with HCPs regarding Azurity’s products
• Collaborate with internal partners to support both the Promotional Material Review Committee (PMRC) and Scientific Review Committee (SRC), to ensure the provision of medical information is accurate and scientifically balanced
• Build a strong relationship and partnership with internal stakeholders (Clinical Development, Commercial/Marketing, Regulatory, Legal, Quality Assurance, Market Access, etc.)
• Collaborate with the broader Medical Affairs team to assist with topic-specific presentations to share new information regarding a product/disease state or help fulfill knowledge gaps
• Assisting with coordinating, escalating and reviewing legal contracts relating to Medical Affairs activities
• Perform other Medical Information-related support and expanded functions, as required

Required Skills and Experience

• A minimum of 1 or more years’ professional experience in Medical Affairs/Medical Information in a pharmaceutical company or 3+ years in a contact/call center working on behalf of a pharmaceutical company

 Preferred Qualifications

• An advanced degree in health sciences (e.g., PharmD, PhD) with a thorough grasp of the pharmaceutical industry is preferred. Masters or bachelor’s level degree in health sciences (e.g., RN, RPh, PA, NP, etc.) would be considered
• Medical/Drug Information postdoctoral training/fellowship in specialty OR residency and/or postdoctoral training in a clinical practice/pharmaceutical industry setting is preferred.

Brief team/department description:

The Manager, Promotional Material Review Committee, is responsible for managing and supporting the end-to-end operations of the Promotional Review Committee (PRC/MRC). This role is responsible for ensuring promotional materials are reviewed efficiently, consistently, and in compliance with regulatory, medical, and legal requirements while enabling timely commercial execution. Reporting to the Director, Medical Education, this role will partner closely with Medical Affairs, Regulatory, Legal, Compliance, and Commercial teams to drive operational excellence, governance, and inspection readiness across promotional review processes.

Principle Responsibilities:

• Manage day-to-day operations of the Promotional Material Review Committee (PRC/MRC), including scheduling, agenda management, and documentation.
• Coordinate review of promotional materials across channels (e.g., HCP, DTC, digital, print, training materials).
• Ensure clear communication of review outcomes, required revisions, and final approvals to stakeholders.
• Translate complex clinical and scientific data into clear, balanced, and compliant medical content for internal and external audiences.
• Support product launches and lifecycle management through review and creation of foundational medical materials.
• Partner with PMRC/SRC stakeholders to facilitate timely review and approval of materials.
• Collaborate closely with Medical Affairs, Regulatory Affairs, Legal, Compliance, Commercial, and Field Medical teams.
• Serve as a medical content subject-matter partner while maintaining appropriate separation between promotional and non-promotional activities.
• Identify opportunities to enhance content quality, efficiency, and alignment with evolving best practices.

Qualifications and Education Requirements

• 5+ years of experience in promotional review, regulatory affairs, medical affairs operations, or compliance within pharmaceutical or biotech organizations.
• Bachelor’s degree required; advanced degree (PharmD, PhD, MD, or MS) in life sciences or related field preferred.
• Experience supporting or managing Promotional Review Committees (PRC/MRC) strongly preferred.
• Familiarity with FDA promotional regulations, OPDP guidance, and advertising/promotion standards.
  
  

Brief team/department description:

Medical Affairs at Azurity Pharmaceuticals, a privately held company delivering innovative medicines for overlooked patients across 50+ countries, drives scientific and clinical initiatives with a portfolio of 30+ brands spanning 10 dosage forms and 9 therapeutic areas. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization. Working at Azurity offers a unique opportunity that combines the fast pace and growth opportunities of a startup with intellectual rigor and creativity.

The Medical Affairs Manager – CORE (Cardiovascular, Obesity, Renal, Endocrinology) is a Hyderabad-based office position within the Medical Affairs Department, reporting to the Medical Lead for the CORE Franchise. The Medical Affairs Manager is responsible for supporting medical strategy to support the safe, effective, and evidence-based use of the company’s products. This role serves as a scientific expert and key liaison between internal teams and external stakeholders, including healthcare professionals (HCPs), key opinion leaders (KOLs), and academic institutions.

Principle Responsibilities:

• Support integrated Medical Affairs strategy aligned with brand objectives and overall corporate priorities.
• Provide scientific and clinical expertise across the full product lifecycle, including pre‑launch planning, launch execution, and post‑marketing support.
• Ensure all medical activities are conducted in accordance with applicable regulatory, legal, compliance, and ethical standards.
• Support and sustain strong relationships with key opinion leaders (KOLs) and other external scientific stakeholders.
• Plan and Support advisory boards, investigator meetings, and scientific symposia to advance scientific understanding and gather actionable insights.
• Support the development, review, and approval of medical materials (e.g., slide decks, FAQs, training content, scientific response documents) and participate in publication planning and execution (abstracts, posters, manuscripts) in close collaboration with Scientific Communications.
• Support stakeholder engagement and education planning in close collaboration with Medical Leads and Stakeholder Engagement Lead 
• Provide strategic medical input into congress planning, scientific content, and on‑site execution.
• Partner cross‑functionally with Clinical Development, Regulatory Affairs, Commercial, Market Access, and Pharmacovigilance to ensure aligned and effective execution of medical strategy.
• Support sales and internal teams through medical training, scientific education, and ongoing clinical guidance.
• Support real‑world evidence (RWE), investigator‑initiated studies (IIS), and post‑marketing studies in collaboration with Clinical Development as needed
• Collaborate with field medical team to analyze medical insights from external engagements to inform medical strategy and lifecycle planning
• Apply all Medical Affairs SOPs, regulatory, legal, and compliance guidelines while executing activities.
• Demonstrate adaptability, focus, and composure in fast-paced settings while operating with minimal direction.

Qualifications and Education Requirements

• Education:
• Advanced terminal degree (PharmD, PhD, MD, DO) OR other advanced medical degree (NP, PA, etc.) w/ 2+ years relevant therapeutic area clinical experience is required.
• Experience:
• 2-3 years relevant work exp (clinical, fellowship, or research experience) and/or related pharmaceutical industry work experience is required.
• Skills:
• Thorough knowledge or experience in cardiology and/or endocrinology is preferred
• Excellent interpersonal and communication skills with a passion for excellence
• Demonstrated ability to present effective and influential oral presentations
• Deep scientific expertise - stays abreast of data, treatment trends, and new information in the profession and ability to articulate therapeutic knowledge and translate expert feedback into appropriate insights
• Strong strategic and operational thinking skills, with the ability to manage effective networks
• Ability to work effectively in a time and independently
• Highly collaborative team player with experience working across cross-functional teams.
• Excellent organization skills and decision-making abilities. Skillfully plans, prioritizes, and executes multiple responsibilities and projects.
• Knowledge of relevant US healthcare systems, the evolving medical landscape, regulatory and payer environment, public health and industry trends.
• Proficiency in digital tools.

Brief team/department description:

Medical Affairs at Azurity Pharmaceuticals, a privately held company delivering innovative medicines for overlooked patients across 50+ countries, drives scientific and clinical initiatives with a portfolio of 30+ brands spanning 10 dosage forms and 9 therapeutic areas. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization. Working at Azurity offers a unique opportunity that combines the fast pace and growth opportunities of a startup with intellectual rigor and creativity.

The Medical Affairs Manager – Oncology is a Hyderabad-based office position within the Medical Affairs Department, reporting to the Medical Lead for the Oncology Franchise. The Medical Affairs Manager is responsible for leading and executing medical strategy to support the safe, effective, and evidence-based use of the company’s products. This role serves as a scientific expert and key liaison between internal teams and external stakeholders, including healthcare professionals (HCPs), key opinion leaders (KOLs), and academic institutions.

Principle Responsibilities:

• Develop and execute an integrated Medical Affairs strategy aligned with brand objectives and overall corporate priorities.
• Serve as a scientific and clinical expert across the full product lifecycle, including pre‑launch planning, launch execution, and post‑marketing support.
• Support and sustain strong relationships with key opinion leaders (KOLs) and other external scientific stakeholders.
• Plan and support advisory boards, investigator meetings, and scientific symposia to advance scientific understanding and gather actionable insights.
• Support the development, review, and approval of medical materials (e.g., slide decks, FAQs, training content) and support publication planning and execution (abstracts, posters, manuscripts) in close collaboration with Scientific Communications.
• Support stakeholder engagement and education planning in close collaboration with Medical Leads and Stakeholder Engagement Lead 
• Provide strategic medical input for conference planning, scientific content, and on‑site execution.
• Partner cross‑functionally with Clinical Development, Regulatory Affairs, Commercial, Market Access, and Pharmacovigilance to ensure aligned and effective execution of medical strategy.
• Support sales and internal teams through medical training, scientific education, and ongoing clinical guidance.
• Support real‑world evidence (RWE), investigator‑initiated studies (IIS), and post‑marketing studies in collaboration with Clinical Development as needed.
• Collaborate with field medical team to analyze medical insights from external engagements to inform medical strategy and lifecycle planning.
• Apply all Medical Affairs SOPs, regulatory, legal, and compliance guidelines while executing activities.
• Demonstrate adaptability, focus, and composure in fast-paced settings while operating with minimal direction.

Qualifications and Education Requirements

• Education:
  • Advanced terminal degree (PharmD, PhD, MD, DO) OR other advanced medical degree (NP, PA, etc.) w/ 1+ years relevant therapeutic area clinical experience is required.
  • Additional oncology-specific certifications (BCOP, AOCNP) highly desirable
• Experience:

• 2-3 years relevant work exp (clinical, fellowship, or research experience) and/or related pharmaceutical industry work experience is required.

• Skills:
  • Thorough knowledge or experience in Hematology/Oncology and/or Immunology is highly preferred
  • Excellent interpersonal and communication skills with a passion for excellence
  • Demonstrated ability to present effective and influential oral presentations
  • Deep scientific expertise - stays abreast of data, treatment trends, and new information in the profession and ability to articulate therapeutic knowledge and translate expert feedback into appropriate insights
  • Strong strategic and operational thinking skills, with the ability to manage effective networks
  • Ability to work effectively in a time and independently
  • Highly collaborative team player with experience working across cross-functional teams.
  • Excellent organization skills and decision-making abilities. Skillfully plans, prioritizes, and executes multiple responsibilities and projects.
  • Knowledge of relevant US healthcare systems, the evolving medical landscape, regulatory and payer environment, public health and industry trends.