GRA CMC Lead
Sanofi
14 days ago
Remote friendly (Morristown, NJ)
United States
$122,250 - $176,583.33 USD yearly
Corporate Functions
Main Responsibilities:
- Develop CMC regulatory strategies and assess associated risks for development projects and/or registered products in collaboration with Global Regulatory Affairs.
- Participate in Change Control assessment.
- Coordinate CMC team collaboration to implement defined regulatory strategies.
- Ensure appropriate strategies are implemented for CMC activities with major regulatory/financial impact; identify, communicate, and address risks.
- Take into account Health Authority requests effectively and timely; develop lasting Health Authority relationships.
- Support strategic negotiations with Global Health Authorities (including FDA and EMA) to reach pragmatic decisions with high probability of success.
- Draft/review supporting documents for Health Authority consultations to define future submission strategy (with R&D and Industrial Affairs).
- Coordinate submission of CMC regulatory files; contribute to preparation/review and monitor/manage post-approval commitments.
- Ensure variation files are prepared according to requirements, quality standards, and timelines.
- Author the CMC strategy document (“Global Regulatory CMC Strategy Document”) as applicable.
- Resolve CMC regulatory issues optimally.
- If applicable, support regulatory inspection processes.
- Contribute to initiatives and review local/international regulations and guidelines; communicate Health Authority requirements.
Qualifications:
Education:
- BS/BA in a relevant scientific discipline (e.g., Biology, Chemistry, Life Sciences) required.
- Advanced degree (PharmD, PhD, MD, DVM, or MSc in Biology/Life Science or related) preferred.
Experience:
- 4+ years in a regulatory role; pharmaceutical industry experience highly valued.
- Operational experience in a medium-to-large organization within Regulatory CMC.
- Knowledge of global regulations/guidelines and Health Authorities’ expectations; ability to solve strategic technical/regulatory problems.
- Initiative, reflection, foresight, and effective communication with internal/external partners.
Benefits (explicitly stated):
- Health and wellbeing benefits, including high-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.
- Develop CMC regulatory strategies and assess associated risks for development projects and/or registered products in collaboration with Global Regulatory Affairs.
- Participate in Change Control assessment.
- Coordinate CMC team collaboration to implement defined regulatory strategies.
- Ensure appropriate strategies are implemented for CMC activities with major regulatory/financial impact; identify, communicate, and address risks.
- Take into account Health Authority requests effectively and timely; develop lasting Health Authority relationships.
- Support strategic negotiations with Global Health Authorities (including FDA and EMA) to reach pragmatic decisions with high probability of success.
- Draft/review supporting documents for Health Authority consultations to define future submission strategy (with R&D and Industrial Affairs).
- Coordinate submission of CMC regulatory files; contribute to preparation/review and monitor/manage post-approval commitments.
- Ensure variation files are prepared according to requirements, quality standards, and timelines.
- Author the CMC strategy document (“Global Regulatory CMC Strategy Document”) as applicable.
- Resolve CMC regulatory issues optimally.
- If applicable, support regulatory inspection processes.
- Contribute to initiatives and review local/international regulations and guidelines; communicate Health Authority requirements.
Qualifications:
Education:
- BS/BA in a relevant scientific discipline (e.g., Biology, Chemistry, Life Sciences) required.
- Advanced degree (PharmD, PhD, MD, DVM, or MSc in Biology/Life Science or related) preferred.
Experience:
- 4+ years in a regulatory role; pharmaceutical industry experience highly valued.
- Operational experience in a medium-to-large organization within Regulatory CMC.
- Knowledge of global regulations/guidelines and Health Authorities’ expectations; ability to solve strategic technical/regulatory problems.
- Initiative, reflection, foresight, and effective communication with internal/external partners.
Benefits (explicitly stated):
- Health and wellbeing benefits, including high-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.