Global Regulatory Strategist
Sanofi
21 days ago
Remote friendly (Morristown, NJ)
United States
$148,500 - $214,500 USD yearly
Corporate Functions
Main Responsibilities
- Provide regulatory input and positioning to internal partners (clinical development, commercial, and the Global Regulatory Team) for assigned projects.
- Liaise with nonclinical, clinical, CMC, commercial, and other internal teams with the Global Regulatory Lead (GRL) to enable successful regulatory outcomes.
- Contribute to a harmonized “One Sanofi” regulatory voice via committees/forums (as directed by the GRL).
- Proactively contribute to GRT strategy (Target Product Profile/TPP, business planning, governance, committees); may lead GRT meetings.
- Develop Health Authority (HA) engagement/interaction plans, including authoring strategy/scientific briefing documents and preparing teams.
- May lead HA meetings/preparations and serve as regional/local regulatory lead and HA point of contact (as needed).
- Lead submission teams/sub-teams to ensure timely filings for:
- Marketing applications: NDA/BLA/MAA/Extensions
- Clinical trial applications: IND/CTA/CTR aligned to trial milestones
- Develop and maintain the core global dossier; collaborate with regional leads on region-specific submissions.
- Lead expedited regulatory pathway development and implementation (FTD, BTD, RMAT, PRIME; Priority Review, Project Orbis, RTOR, Conditional Approval).
- Execute operational/compliance deliverables: generate submission content plans; track progress/milestones; leverage cross-functional teams/alliance partners.
Qualifications
- BS/BA in scientific discipline or MSc (Biology/Life Science or related) + at least 8 years pharma/biotech experience, including 6 years Regulatory Affairs in oncology, OR
- PharmD/PhD/MD/DVM + at least 4 years pharma/biotech/regulatory experience, including 2 years Regulatory Affairs in oncology.
Skills (Required/Preferred)
- Preferred: understanding of clinical development for drugs/innovative biologics.
- Desirable: experience preparing regulatory documents (e.g., (s)BLA/(s)NDA/MAA, INDs/CTAs, HA briefing docs) and negotiating with national/regional HAs.
- Desirable: experience with electronic document management systems (e.g., Veeva Vault RIM, Plai).
- Plus: experience using AI platforms for regulatory environment/best practices.
- Effective oral and written communication; multicultural/multinational sensitivity; leadership/influencing/negotiation; ability to build networks and lead stakeholder discussions.
- Provide regulatory input and positioning to internal partners (clinical development, commercial, and the Global Regulatory Team) for assigned projects.
- Liaise with nonclinical, clinical, CMC, commercial, and other internal teams with the Global Regulatory Lead (GRL) to enable successful regulatory outcomes.
- Contribute to a harmonized “One Sanofi” regulatory voice via committees/forums (as directed by the GRL).
- Proactively contribute to GRT strategy (Target Product Profile/TPP, business planning, governance, committees); may lead GRT meetings.
- Develop Health Authority (HA) engagement/interaction plans, including authoring strategy/scientific briefing documents and preparing teams.
- May lead HA meetings/preparations and serve as regional/local regulatory lead and HA point of contact (as needed).
- Lead submission teams/sub-teams to ensure timely filings for:
- Marketing applications: NDA/BLA/MAA/Extensions
- Clinical trial applications: IND/CTA/CTR aligned to trial milestones
- Develop and maintain the core global dossier; collaborate with regional leads on region-specific submissions.
- Lead expedited regulatory pathway development and implementation (FTD, BTD, RMAT, PRIME; Priority Review, Project Orbis, RTOR, Conditional Approval).
- Execute operational/compliance deliverables: generate submission content plans; track progress/milestones; leverage cross-functional teams/alliance partners.
Qualifications
- BS/BA in scientific discipline or MSc (Biology/Life Science or related) + at least 8 years pharma/biotech experience, including 6 years Regulatory Affairs in oncology, OR
- PharmD/PhD/MD/DVM + at least 4 years pharma/biotech/regulatory experience, including 2 years Regulatory Affairs in oncology.
Skills (Required/Preferred)
- Preferred: understanding of clinical development for drugs/innovative biologics.
- Desirable: experience preparing regulatory documents (e.g., (s)BLA/(s)NDA/MAA, INDs/CTAs, HA briefing docs) and negotiating with national/regional HAs.
- Desirable: experience with electronic document management systems (e.g., Veeva Vault RIM, Plai).
- Plus: experience using AI platforms for regulatory environment/best practices.
- Effective oral and written communication; multicultural/multinational sensitivity; leadership/influencing/negotiation; ability to build networks and lead stakeholder discussions.