Global Regulatory Lead
Sanofi
June 30, 2026
Remote friendly (Morristown, NJ)
United States
$178,500 - $257,833.33 USD yearly
Corporate Functions
Main Responsibilities:
- Lead development and execution of global regulatory strategies; formulate Global Regulatory Project Strategy (GRPS), Global Submission Strategy, and core product labeling; manage product life cycle and contribute to the Target Product Profile (TPP).
- Lead Global Regulatory Team (GRT) performance: align on mission/priorities/objectives, set clear expectations and global labeling strategy, supervise/coach, and build a feedback culture; develop Regulatory Strategists as appropriate.
- Ensure internal/external alignment as “one GRA voice” with TA, GBU Head, and GRA LT as needed to advocate regulatory positions to governance/committees; share outcomes with GRT and cross-functional partners.
- Identify regulatory acceleration opportunities; take thoughtful risks; make final decisions on regulatory success rates and mitigations on behalf of GRT.
- Monitor and interpret global regulatory environments; leverage Regional experts to ensure robust strategy; determine updates to regulatory strategy.
- Lead global Health Authority (HA) interaction plan/strategy with GRT; communicate key outcomes to senior management.
- Advance organizational goals through leadership in professional associations/industry/trade groups for assigned therapeutic area/projects.
Requirements:
- BS/BA in relevant scientific discipline (required). Advanced degree (PharmD/PhD/MD/DVM/MSc) preferred.
- 8–10+ years pharma/biotech experience; 6+ years Regulatory Affairs (regional/global), development phase; oncology experience required.
- Expert regulatory strategic experience and strong regulatory environment knowledge.
- Strategic leadership in business-critical development programs; accountable for defending global regulatory strategies at Global Project Teams (or equivalent).
- Experience leading Health Authority interactions in major markets.
- Experience preparing (s)BLA/(s)NDA/MAA, INDs, HA briefing documents, and negotiating with HA (e.g., US/EU).
- Experience leading filings/registrations and obtaining regulatory actions in major markets.
- Project leadership; experience leading teams/developing internal talent.
Benefits (explicitly stated):
- At least 14 weeks’ gender-neutral parental leave; high-quality healthcare, prevention and wellness programs.
- Lead development and execution of global regulatory strategies; formulate Global Regulatory Project Strategy (GRPS), Global Submission Strategy, and core product labeling; manage product life cycle and contribute to the Target Product Profile (TPP).
- Lead Global Regulatory Team (GRT) performance: align on mission/priorities/objectives, set clear expectations and global labeling strategy, supervise/coach, and build a feedback culture; develop Regulatory Strategists as appropriate.
- Ensure internal/external alignment as “one GRA voice” with TA, GBU Head, and GRA LT as needed to advocate regulatory positions to governance/committees; share outcomes with GRT and cross-functional partners.
- Identify regulatory acceleration opportunities; take thoughtful risks; make final decisions on regulatory success rates and mitigations on behalf of GRT.
- Monitor and interpret global regulatory environments; leverage Regional experts to ensure robust strategy; determine updates to regulatory strategy.
- Lead global Health Authority (HA) interaction plan/strategy with GRT; communicate key outcomes to senior management.
- Advance organizational goals through leadership in professional associations/industry/trade groups for assigned therapeutic area/projects.
Requirements:
- BS/BA in relevant scientific discipline (required). Advanced degree (PharmD/PhD/MD/DVM/MSc) preferred.
- 8–10+ years pharma/biotech experience; 6+ years Regulatory Affairs (regional/global), development phase; oncology experience required.
- Expert regulatory strategic experience and strong regulatory environment knowledge.
- Strategic leadership in business-critical development programs; accountable for defending global regulatory strategies at Global Project Teams (or equivalent).
- Experience leading Health Authority interactions in major markets.
- Experience preparing (s)BLA/(s)NDA/MAA, INDs, HA briefing documents, and negotiating with HA (e.g., US/EU).
- Experience leading filings/registrations and obtaining regulatory actions in major markets.
- Project leadership; experience leading teams/developing internal talent.
Benefits (explicitly stated):
- At least 14 weeks’ gender-neutral parental leave; high-quality healthcare, prevention and wellness programs.