Global Regulatory Lead

Responsibilities

• Lead the development and execution of innovative global regulatory strategies, including Global Regulatory Project Strategy (GRPS) and Global Submission Strategy.
• Act as the primary strategic regulatory partner for the Global Project Team (GPT) and Global Brand Team (GBT).
• Formulate core product labeling for products in development and manage life cycle strategies.
• Lead the Global Regulatory Team (GRT) by setting clear objectives, fostering a feedback culture, and coaching regulatory strategists.
• Develop and lead global Health Authority (HA) interaction plans and strategies in collaboration with cross-functional partners.
• Monitor and interpret the global regulatory environment to ensure robust and competitive product profiles.
• Advocate for regulatory positions to internal governance committees and senior management.

Requirements

• BS/BA degree in a relevant scientific discipline (Advanced degree such as PharmD, PhD, MD, or MSc preferred).
• 8-10 years of experience in the pharmaceutical or biotechnology industry.
• At least 6 years of dedicated Regulatory Affairs experience, specifically in the development phase.
• Proven experience in Oncology.
• Demonstrated expertise in developing and defending innovative regulatory strategies within high-profile development programs.
• Experience leading Health Authority interactions in major markets (e.g., US, EU).
• Experience with regulatory filings such as (s)BLA, (s)NDA, MAA, or INDs.
• Strong project leadership and experience developing internal talent.

Benefits

• Thoughtful, well-crafted rewards package.
• Wide range of health and wellbeing benefits, including high-quality healthcare and wellness programs.
• At least 14 weeks of gender-neutral parental leave.
• Opportunities for career growth through internal promotions or lateral moves.

About the Company

Sanofi is an R&D-driven, AI-powered biopharma company committed to improving people’s lives. By leveraging a deep understanding of the immune system and cutting-edge innovation, Sanofi develops medicines and vaccines that treat and protect millions of people worldwide.