Global Regulatory Lead
Sanofi
June 30, 2026
Remote friendly (Cambridge, MA)
United States
$178,500 - $257,833.33 USD yearly
Corporate Functions
Main Responsibilities
- Lead the development and execution of global regulatory strategies; formulate Global Regulatory Project Strategy (GRPS), Global Submission Strategy, and core product labeling, including lifecycle management and proactive contribution to the Target Product Profile (TPP).
- Lead the Global Regulatory Team (GRT) by aligning the team on mission, prioritization, objectives, and expectations for the Global Regulatory Strategy and Plan; supervise, coach, facilitate feedback culture, and develop Regulatory Strategists (RS) as appropriate.
- Ensure internal and external alignment/communication as “one GRA voice” with TA, GBU Head, and GRA LT as needed; advocate regulatory positions to governance/committees and share outcomes with GRT and cross-functional partners.
- Identify regulatory acceleration opportunities; take thoughtful risks and make final regulatory success-rate and mitigation decisions on behalf of the GRT.
- Monitor and interpret global regulatory environments; leverage regional expertise and update regulatory strategy as needed.
- Develop global Health Authority (HA) interaction plans/strategy with GRT; communicate key outcomes to senior management.
- Participate in and take leadership roles in professional associations and industry/trade groups as appropriate.
Requirements
- BS/BA in a relevant scientific discipline required; PharmD/PhD/MD/DVM/MSc (Biology/Life Science or related) preferred.
- 8–10+ years pharmaceutical/biotech experience; 6+ years Regulatory Affairs (regional and/or global), development phase, with oncology experience.
- Expert regulatory strategic experience and understanding of the regulatory environment.
- Strategic leadership experience developing/defending global regulatory strategies; accountable at Global Project Teams or equivalent.
- Prior leading Health Authority interactions in major markets.
- Experience preparing (s)BLA/(s)NDA/MAA, INDs, HA meeting briefing documents; negotiating with national/regional Health Authorities (e.g., US/EU).
- Experience leading filings/registrations and obtaining regulatory actions in major markets.
- Project leadership; experience leading teams and/or developing talent.
- Lead the development and execution of global regulatory strategies; formulate Global Regulatory Project Strategy (GRPS), Global Submission Strategy, and core product labeling, including lifecycle management and proactive contribution to the Target Product Profile (TPP).
- Lead the Global Regulatory Team (GRT) by aligning the team on mission, prioritization, objectives, and expectations for the Global Regulatory Strategy and Plan; supervise, coach, facilitate feedback culture, and develop Regulatory Strategists (RS) as appropriate.
- Ensure internal and external alignment/communication as “one GRA voice” with TA, GBU Head, and GRA LT as needed; advocate regulatory positions to governance/committees and share outcomes with GRT and cross-functional partners.
- Identify regulatory acceleration opportunities; take thoughtful risks and make final regulatory success-rate and mitigation decisions on behalf of the GRT.
- Monitor and interpret global regulatory environments; leverage regional expertise and update regulatory strategy as needed.
- Develop global Health Authority (HA) interaction plans/strategy with GRT; communicate key outcomes to senior management.
- Participate in and take leadership roles in professional associations and industry/trade groups as appropriate.
Requirements
- BS/BA in a relevant scientific discipline required; PharmD/PhD/MD/DVM/MSc (Biology/Life Science or related) preferred.
- 8–10+ years pharmaceutical/biotech experience; 6+ years Regulatory Affairs (regional and/or global), development phase, with oncology experience.
- Expert regulatory strategic experience and understanding of the regulatory environment.
- Strategic leadership experience developing/defending global regulatory strategies; accountable at Global Project Teams or equivalent.
- Prior leading Health Authority interactions in major markets.
- Experience preparing (s)BLA/(s)NDA/MAA, INDs, HA meeting briefing documents; negotiating with national/regional Health Authorities (e.g., US/EU).
- Experience leading filings/registrations and obtaining regulatory actions in major markets.
- Project leadership; experience leading teams and/or developing talent.