Regulatory Strategist
Sanofi
2 months ago
Remote friendly (Cambridge, MA)
United States
Corporate Functions
Main Responsibilities:
- Provide quality regulatory input and position to internal business partners (clinical development teams, commercial, and GRT) for assigned projects.
- Contribute to the GRT for assigned projects by providing strategic input on the Target Product Profile (TPP), business planning, governance, and committees; may lead GRT meetings.
- Contribute to the Global Regulatory Project Strategy (GRPS) and ensure alignment with core product labeling for development and lifecycle management.
- Serve as regional/local regulatory lead and point of contact with Health Authorities (HAs) for assigned projects/products, as needed.
- Develop HA engagement/interaction plans, author HA briefing documents (strategy and scientific content), lead meeting preparations, and moderate meetings for assigned projects; may lead HA meetings/preparations.
- Lead submission teams/regulatory sub-teams to ensure NDA/BLA/MAA/Extensions filings meet project timelines; develop and update core global dossier and collaborate with regional leads for region-specific submissions.
- Lead IND/CTA submission strategy to ensure timelines support clinical trial initiation.
- Support operational and compliance activities for deliverables; plan and execute regulatory submission activities (content plans, tracking, document management) with cross-functional and/or alliance partner input.
Qualifications:
- BS/BA in relevant scientific discipline required; PharmD/PhD/MD/DVM/MSc (Biology, Life Science, or related) preferred.
- 6+ years relevant pharmaceutical/biotech experience, including 4+ years Regulatory Affairs experience (regional and global) across early/late-stage development of multiple modalities; regulatory CMC experience not directly applicable.
- Demonstrated experience preparing (s)BLA/(s)NDA/MAA, INDs/CTAs, HA briefing documents; negotiating with national/regional HAs preferred.
- Experience on multidisciplinary matrixed project teams preferred.
- Project leadership experience preferred.
Benefits:
- Health and wellbeing benefits, including high-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.
- Provide quality regulatory input and position to internal business partners (clinical development teams, commercial, and GRT) for assigned projects.
- Contribute to the GRT for assigned projects by providing strategic input on the Target Product Profile (TPP), business planning, governance, and committees; may lead GRT meetings.
- Contribute to the Global Regulatory Project Strategy (GRPS) and ensure alignment with core product labeling for development and lifecycle management.
- Serve as regional/local regulatory lead and point of contact with Health Authorities (HAs) for assigned projects/products, as needed.
- Develop HA engagement/interaction plans, author HA briefing documents (strategy and scientific content), lead meeting preparations, and moderate meetings for assigned projects; may lead HA meetings/preparations.
- Lead submission teams/regulatory sub-teams to ensure NDA/BLA/MAA/Extensions filings meet project timelines; develop and update core global dossier and collaborate with regional leads for region-specific submissions.
- Lead IND/CTA submission strategy to ensure timelines support clinical trial initiation.
- Support operational and compliance activities for deliverables; plan and execute regulatory submission activities (content plans, tracking, document management) with cross-functional and/or alliance partner input.
Qualifications:
- BS/BA in relevant scientific discipline required; PharmD/PhD/MD/DVM/MSc (Biology, Life Science, or related) preferred.
- 6+ years relevant pharmaceutical/biotech experience, including 4+ years Regulatory Affairs experience (regional and global) across early/late-stage development of multiple modalities; regulatory CMC experience not directly applicable.
- Demonstrated experience preparing (s)BLA/(s)NDA/MAA, INDs/CTAs, HA briefing documents; negotiating with national/regional HAs preferred.
- Experience on multidisciplinary matrixed project teams preferred.
- Project leadership experience preferred.
Benefits:
- Health and wellbeing benefits, including high-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.