Global Regulatory Strategist
Sanofi
9 hours ago
Remote friendly (Cambridge, MA)
United States
$148,500 - $214,500 USD yearly
Corporate Functions
Main Responsibilities
- Enable the Global Regulatory Lead (GRL) by providing quality regulatory input and positioning to internal partners (clinical development, commercial, and Global Regulatory Team) for assigned projects.
- Liaise with nonclinical, clinical, CMC, commercial, and other internal partners to enable successful regulatory outcomes.
- Contribute to a harmonized “One Sanofi” regulatory voice via committees/forums (as directed by GRL).
- Provide strategic input on Target Product Profile (TPP), business planning, governance, and committees; may lead GRT meetings.
Health Authority (HA) Engagement
- Develop HA engagement/interaction plans, including authoring strategy/scientific briefing documents and leading meeting preparations.
- May lead HA meetings/preparations as designated.
- May serve as regional/local regulatory lead and point of contact with Health Authorities as needed.
Regulatory Submissions & Operations
- Lead submission teams/sub-teams to ensure timely filings for:
- Marketing applications: NDA/BLA/MAA/Extensions
- Clinical trial applications: IND/CTA/CTR aligned with trial initiation milestones
- Develop and maintain the core global dossier; collaborate with regional leads on region-specific submissions.
- Lead expedited regulatory pathways (FTD, BTD, RMAT, PRIME) and review processes (Priority Review, Project Orbis, RTOR, Conditional Approval).
- Execute operational/compliance activities: generate submission content plans; track progress/milestones; leverage cross-functional teams and alliance partners.
Qualifications
- BS/BA in a scientific discipline or MSc (Biology/Life Science/related) + 8+ years pharma/biotech experience, incl. 6+ years Regulatory Affairs in oncology; OR
- PharmD/PhD/MD/DVM + 4+ years pharma/biotech/regulatory experience, incl. 2+ years Regulatory Affairs in oncology.
Technical/Preferred Skills
- Preferred: clinical development knowledge of drugs/innovative biologics.
- Desirable: preparing regulatory documents and negotiating with national/regional Health Authorities.
- Desirable: electronic document management systems (e.g., Veeva Vault RIM, Plai).
- Plus: experience using AI platforms for establishing regulatory environment/best practices.
Soft Skills
- Strong oral and written communication; presentation skills.
- Ability to work in multicultural/multinational environments; leadership/influencing/negotiation.
Benefits (explicitly stated)
- Wide range of health and wellbeing benefits, including high-quality healthcare, prevention/wellness programs, and at least 14 weeks’ gender-neutral parental leave.
- Enable the Global Regulatory Lead (GRL) by providing quality regulatory input and positioning to internal partners (clinical development, commercial, and Global Regulatory Team) for assigned projects.
- Liaise with nonclinical, clinical, CMC, commercial, and other internal partners to enable successful regulatory outcomes.
- Contribute to a harmonized “One Sanofi” regulatory voice via committees/forums (as directed by GRL).
- Provide strategic input on Target Product Profile (TPP), business planning, governance, and committees; may lead GRT meetings.
Health Authority (HA) Engagement
- Develop HA engagement/interaction plans, including authoring strategy/scientific briefing documents and leading meeting preparations.
- May lead HA meetings/preparations as designated.
- May serve as regional/local regulatory lead and point of contact with Health Authorities as needed.
Regulatory Submissions & Operations
- Lead submission teams/sub-teams to ensure timely filings for:
- Marketing applications: NDA/BLA/MAA/Extensions
- Clinical trial applications: IND/CTA/CTR aligned with trial initiation milestones
- Develop and maintain the core global dossier; collaborate with regional leads on region-specific submissions.
- Lead expedited regulatory pathways (FTD, BTD, RMAT, PRIME) and review processes (Priority Review, Project Orbis, RTOR, Conditional Approval).
- Execute operational/compliance activities: generate submission content plans; track progress/milestones; leverage cross-functional teams and alliance partners.
Qualifications
- BS/BA in a scientific discipline or MSc (Biology/Life Science/related) + 8+ years pharma/biotech experience, incl. 6+ years Regulatory Affairs in oncology; OR
- PharmD/PhD/MD/DVM + 4+ years pharma/biotech/regulatory experience, incl. 2+ years Regulatory Affairs in oncology.
Technical/Preferred Skills
- Preferred: clinical development knowledge of drugs/innovative biologics.
- Desirable: preparing regulatory documents and negotiating with national/regional Health Authorities.
- Desirable: electronic document management systems (e.g., Veeva Vault RIM, Plai).
- Plus: experience using AI platforms for establishing regulatory environment/best practices.
Soft Skills
- Strong oral and written communication; presentation skills.
- Ability to work in multicultural/multinational environments; leadership/influencing/negotiation.
Benefits (explicitly stated)
- Wide range of health and wellbeing benefits, including high-quality healthcare, prevention/wellness programs, and at least 14 weeks’ gender-neutral parental leave.