Regulatory Strategist
Sanofi
June 30, 2026
Remote friendly (Morristown, NJ)
United States
$148,500 - $214,500 USD yearly
Corporate Functions
Main Responsibilities:
- Provide quality regulatory input and position to internal business partners (clinical development, commercial, and GRT) for assigned projects.
- Contribute to GRT strategy for assigned projects, including strategic input on Target Product Profile (TPP), business planning, governance, and committees; may lead GRT meetings.
- Develop 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) as needed.
- Develop HA engagement and interaction plans, author briefing documents (strategy and scientific content), lead meeting preparations, and moderate meetings; may lead HA meetings/preparations.
- Lead submission team/sub-team to ensure NDA/BLA/MAA/Extensions filings meet product launch timelines; develop/update core global dossier and collaborate with regional leads for region-specific submissions.
- Lead IND/CTA submission strategy to meet timelines for clinical trial initiation.
- Support operational/compliance activities for deliverables, including regulatory submission planning, content plans, tracking, and document management with cross-functional/alliance inputs.
Qualifications:
- Required: BS/BA in a relevant scientific discipline.
- Preferred: PharmD, PhD, MD, DVM, or MSc in Biology/Life Science/related field.
- Required: 6+ years relevant pharmaceutical/biotech experience, including 4+ years Regulatory Affairs (regional/global), early/late-stage, multiple modalities; regulatory CMC not directly applicable.
- Preferred: Experience preparing (s)BLA/(s)NDA/MAA, INDs/CTAs, HA briefing documents; negotiating with national/regional HAs; experience on multidisciplinary matrixed teams; project leadership experience.
Benefits:
- Health and wellbeing benefits; high-quality healthcare and prevention/wellness programs; at least 14 weeks’ gender-neutral parental leave.
- Provide quality regulatory input and position to internal business partners (clinical development, commercial, and GRT) for assigned projects.
- Contribute to GRT strategy for assigned projects, including strategic input on Target Product Profile (TPP), business planning, governance, and committees; may lead GRT meetings.
- Develop 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) as needed.
- Develop HA engagement and interaction plans, author briefing documents (strategy and scientific content), lead meeting preparations, and moderate meetings; may lead HA meetings/preparations.
- Lead submission team/sub-team to ensure NDA/BLA/MAA/Extensions filings meet product launch timelines; develop/update core global dossier and collaborate with regional leads for region-specific submissions.
- Lead IND/CTA submission strategy to meet timelines for clinical trial initiation.
- Support operational/compliance activities for deliverables, including regulatory submission planning, content plans, tracking, and document management with cross-functional/alliance inputs.
Qualifications:
- Required: BS/BA in a relevant scientific discipline.
- Preferred: PharmD, PhD, MD, DVM, or MSc in Biology/Life Science/related field.
- Required: 6+ years relevant pharmaceutical/biotech experience, including 4+ years Regulatory Affairs (regional/global), early/late-stage, multiple modalities; regulatory CMC not directly applicable.
- Preferred: Experience preparing (s)BLA/(s)NDA/MAA, INDs/CTAs, HA briefing documents; negotiating with national/regional HAs; experience on multidisciplinary matrixed teams; project leadership experience.
Benefits:
- Health and wellbeing benefits; high-quality healthcare and prevention/wellness programs; at least 14 weeks’ gender-neutral parental leave.