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Senior Director of CMC Regulatory Affairs
3 months ago
Overview
At Servier Group, a prominent global organization with a strong presence in over 150 countries, we are dedicated to advancing healthcare through innovative therapies. Our focus on oncology and other critical disease areas drives our commitment to research and development, ensuring we meet the needs of patient communities worldwide.
Position Summary
The Senior Director of CMC Regulatory Affairs plays a pivotal role in overseeing regulatory strategies for biotechnology products. This position requires a seasoned professional with extensive experience in regulatory CMC activities, specifically in the context of Marketing Authorization Applications (MAAs) and Biologics License Applications (BLAs). You will collaborate closely with key stakeholders to establish and implement CMC regulatory strategies that align with our organizational goals.
Key Responsibilities
- Develop and execute comprehensive global regulatory CMC strategies for both investigational and marketed products, ensuring alignment with product development and lifecycle management.
- Manage the regulatory CMC components of projects, including the preparation and submission of CMC sections for clinical trial applications and marketing applications across various regions (e.g., US, EU, China).
- Coordinate lifecycle management activities, including variations and renewals, at an international level.
- Represent Regulatory Affairs CMC in cross-functional teams, collaborating with Manufacturing, Quality, and Supply Chain to ensure compliance and strategic alignment.
- Prepare CMC documentation in response to inquiries from Health Authorities, including briefing materials for Scientific Advice meetings.
- Oversee specific quality and regulatory tasks, such as managing Out Of Specification (OOS) results and ensuring adherence to regulatory commitments.
- Contribute to Change Control processes, conducting regulatory impact analyses as necessary.
- Ensure compliance with the company's Quality Manual and regulatory standards.
Qualifications and Skills
- Bachelor's degree in a relevant scientific discipline (e.g., biotechnology, biology, pharmacy) is required; advanced degrees (MS or PhD) are preferred, along with a minimum of 10 years of experience in CMC/Regulatory CMC within the pharmaceutical industry.
- Proven experience in preparing and overseeing CMC submissions, including INDs, IMPDs, NDAs, and MAAs.
- In-depth knowledge of eCTD requirements, particularly Module 3, and familiarity with global regulatory guidelines.
- Strong collaborative skills, with a history of working effectively within cross-functional teams.
- Excellent analytical, problem-solving, and organizational abilities.
- Strong attention to detail and exceptional verbal and written communication skills.
- Experience in navigating regulatory frameworks in the US, EU, and other key international markets.
Additional Information
- Minimal travel is expected (less than 20%).
- Remote work options are available.
Commitment to Diversity
Servier Group is committed to fostering a diverse and inclusive workplace. We welcome applicants from all backgrounds and experiences, and we are dedicated to ensuring equitable treatment for all individuals.
Compensation
The salary range for this position is competitive and commensurate with experience, along with eligibility for various incentive programs and a comprehensive benefits package.
