Regulatory Strategist – Innovation Franchise
| Company | Sanofi |
|---|---|
| Location | Cambridge, MA, USA, Morristown, NJ, USA |
| Salary | $122250 – $176583.33 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PharmD, PhD, JD, MD |
| Experience Level | Senior |
Requirements
- BS/BA degree in a relevant scientific discipline or MSc in Biology, Life Science, or related field with at least 5 years of relevant pharmaceutical/biotechnology industry experience, including at least 3 years of relevant Regulatory Affairs experience in the United States or Advanced degree (PharmD, PhD, MD or DVM) with at least 2 years of regulatory or relevant
- Significant track record of US regulatory expertise required (demonstrated experience with preparation of NMAs, LCM activities, briefing documents) and negotiating with the US FDA.
- Experience with acceleration pathways (Orphan Drug, Breakthrough Therapy…), pediatric and clinical trial regulations as well as novel methodologies for regulatory decision making (RWE, patient focused drug development).
- Digital training and understanding on Sanofi Digital Transformation (AI role)
Responsibilities
- Enables the Global Regulatory Lead (GRL) by providing quality regulatory input and positions to internal business partners, including but not limited to clinical development teams, commercial teams, and the Global Regulatory Team for assigned projects within the GenMed Innovation Franchise.
- Liaise with clinical, medical, commercial, supply functions, and other internal business stakeholders in partnership with the GRL to enable successful regulatory outcomes.
- Contribute to the development of a harmonized, One Sanofi regulatory voice by providing strategic input through participation in appropriate governance committees and forums at the direction of the GRL. May represent Global Regulatory Team’s strategic position on behalf of the GRL at regulatory forums/committees at the request of GRL.
- Serve as the regional/local point of contact with Health Authorities including FDA for the GenMed Innovation Products. Contribute to the development of FDA interaction strategy, lead Health Authorities meetings, and lead the team through meeting preparations.
- Identify regulatory risks and propose mitigations in collaboration with the GRL.
- Contribute to the development of Global Regulatory Project Strategy (GRPS) and ensure alignment with the core product labeling for GenMed Innovation Products in their remit.
- Assess and interpret the global regulatory and competitive environments, leveraging expertise in commercial competitive intelligence and other parts of GRA (e.g. Regional experts and Regulatory Science and Policy) to ensure the most robust strategy possible and determine any necessary updates to the regulatory strategy.
- Lead the IND/CTA submission strategy to ensure preparation timelines meet the project timelines for clinical trial initiation.
- May lead submission teams or regulatory sub teams to ensure regulatory filings meet the project timelines for product launch.
- Contribute to content and review regulated documents (such as IB, PBRER, DSUR, RMP, etc.).
- Support operational and compliance activities for assigned regulatory deliverables and develop regulatory submission planning, including submission tracking in the electronic document management system.
- Accountable for regulatory assessment for Due Diligence activities as applicable through the partnership with GRA Strategy and Business Optimization.
Preferred Qualifications
- Project leadership experience preferred.