Regulatory Strategist
Sanofi
June 30, 2026
Remote friendly (Cambridge, MA)
United States
$148,500 - $214,500 USD yearly
Other
Main Responsibilities:
- Provide quality regulatory input/position to internal partners (clinical development, commercial, and Global Regulatory Team) for assigned projects.
- Contribute to Global Regulatory Team (GRT) strategy for assigned projects, including Target Product Profile (TPP), business planning, governance, and committees; may lead GRT meetings.
- Develop 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/interaction plans; author HA briefing documents (strategy and scientific content); lead meeting preparations and moderate meetings.
- Lead HA meetings/preparations as designated.
- Lead submission team/regulatory sub-team to ensure NDA/BLA/MAA/Extensions filings meet project timelines; develop/update core global dossier and collaborate on region-specific submissions.
- Lead IND/CTA submission strategy to meet timelines for clinical trial initiation.
- Support operational/compliance activities and regulatory submission planning (submission content plans, tracking, and document management).
Qualifications:
- Minimum BS/BA in a relevant scientific discipline required; advanced degree (PharmD/PhD/MD/DVM or MSc in Biology/Life Science/related) preferred.
- At least 6 years relevant pharmaceutical/biotech experience, including at least 4 years Regulatory Affairs (regional/global), covering 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; preferred: negotiating with national/regional HAs.
- Preferred: experience on multidisciplinary matrixed teams; project leadership experience preferred.
- Provide quality regulatory input/position to internal partners (clinical development, commercial, and Global Regulatory Team) for assigned projects.
- Contribute to Global Regulatory Team (GRT) strategy for assigned projects, including Target Product Profile (TPP), business planning, governance, and committees; may lead GRT meetings.
- Develop 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/interaction plans; author HA briefing documents (strategy and scientific content); lead meeting preparations and moderate meetings.
- Lead HA meetings/preparations as designated.
- Lead submission team/regulatory sub-team to ensure NDA/BLA/MAA/Extensions filings meet project timelines; develop/update core global dossier and collaborate on region-specific submissions.
- Lead IND/CTA submission strategy to meet timelines for clinical trial initiation.
- Support operational/compliance activities and regulatory submission planning (submission content plans, tracking, and document management).
Qualifications:
- Minimum BS/BA in a relevant scientific discipline required; advanced degree (PharmD/PhD/MD/DVM or MSc in Biology/Life Science/related) preferred.
- At least 6 years relevant pharmaceutical/biotech experience, including at least 4 years Regulatory Affairs (regional/global), covering 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; preferred: negotiating with national/regional HAs.
- Preferred: experience on multidisciplinary matrixed teams; project leadership experience preferred.