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