Regulatory Strategist
Sanofi
August 24, 2026
On-site
Morristown, NJ
$122,250 - $176,583.33 USD yearly
Corporate Functions
Main Responsibilities:
- Provide quality regulatory input/position to clinical development, commercial, and Global Regulatory Team (GRT) for assigned projects; liaise with cross-functional partners to enable successful regulatory outcomes.
- Contribute to a harmonized regulatory voice via committees/forums; may represent GRL/GRT position at regulatory forums.
- Serve as regional/local regulatory lead and point of contact with Health Authorities (HAs) as needed; develop HA engagement/interaction plans and briefing strategy/scientific content.
- Identify regulatory risks and propose mitigations with GRL and cross-functional teams.
- Contribute to Global Regulatory Project Strategy; ensure alignment with core vaccine labeling.
- Ensure team members have needed information to develop/execute global regulatory strategy.
- Lead submission/regulatory sub-teams to ensure NDA/BLA/MAA/Extensions filings meet launch timelines; develop/update core global dossier and collaborate on region-specific submissions.
- Lead IND/CTA submission strategy for clinical trial initiation timelines.
- Contribute to/review regulated documents (e.g., IB, PBRER, DSUR, RMP).
- Support operational/compliance deliverables; manage submission planning (content plans, tracking, document management) and ensure complete/accurate HA communications (including tracking).
Education & Experience:
- Bachelor’s in relevant scientific discipline or MSc (Biology/Life Science/related) + 5+ years pharma/biotech experience with 3+ years Regulatory Affairs, OR
- PharmD/PhD/MD/DVM + 2+ years regulatory or relevant pharma/biotech experience.
Technical & Soft Skills:
- Understanding of clinical development of drugs/novel biologics (vaccines a plus).
- Experience with electronic document management systems (e.g., Veeva Vault a plus); manage multiple projects/deliverables.
- Business acumen; leadership/influencing/negotiation; effective oral/written communication; comfort in multicultural/multinational environments.
Benefits (as stated):
- Healthcare and prevention/wellness programs; at least 14 weeks’ gender-neutral parental leave.
- Provide quality regulatory input/position to clinical development, commercial, and Global Regulatory Team (GRT) for assigned projects; liaise with cross-functional partners to enable successful regulatory outcomes.
- Contribute to a harmonized regulatory voice via committees/forums; may represent GRL/GRT position at regulatory forums.
- Serve as regional/local regulatory lead and point of contact with Health Authorities (HAs) as needed; develop HA engagement/interaction plans and briefing strategy/scientific content.
- Identify regulatory risks and propose mitigations with GRL and cross-functional teams.
- Contribute to Global Regulatory Project Strategy; ensure alignment with core vaccine labeling.
- Ensure team members have needed information to develop/execute global regulatory strategy.
- Lead submission/regulatory sub-teams to ensure NDA/BLA/MAA/Extensions filings meet launch timelines; develop/update core global dossier and collaborate on region-specific submissions.
- Lead IND/CTA submission strategy for clinical trial initiation timelines.
- Contribute to/review regulated documents (e.g., IB, PBRER, DSUR, RMP).
- Support operational/compliance deliverables; manage submission planning (content plans, tracking, document management) and ensure complete/accurate HA communications (including tracking).
Education & Experience:
- Bachelor’s in relevant scientific discipline or MSc (Biology/Life Science/related) + 5+ years pharma/biotech experience with 3+ years Regulatory Affairs, OR
- PharmD/PhD/MD/DVM + 2+ years regulatory or relevant pharma/biotech experience.
Technical & Soft Skills:
- Understanding of clinical development of drugs/novel biologics (vaccines a plus).
- Experience with electronic document management systems (e.g., Veeva Vault a plus); manage multiple projects/deliverables.
- Business acumen; leadership/influencing/negotiation; effective oral/written communication; comfort in multicultural/multinational environments.
Benefits (as stated):
- Healthcare and prevention/wellness programs; at least 14 weeks’ gender-neutral parental leave.