Director, Global Regulatory Affairs – Global Labeling Strategy
Sanofi
Morristown, NJ
19 hours ago
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Job Description
Join Sanofi as the Director of Global Regulatory Affairs, where you will lead global labeling strategies for pharmaceutical products, ensuring compliance with regulatory standards while mentoring a team. This role is pivotal in shaping the future of medicine, contributing to drug development and patient care.
Key Responsibilities
Lead the development, maintenance, and alignment of global labeling strategy and content.
Provide regulatory labeling leadership to cross-functional teams.
Contribute to early development programs by identifying labeling-relevant clinical endpoints.
Assess opportunities for the integration of patient experience data.
Represent Global Labeling on global regulatory teams.
Coordinate end-to-end labeling processes.
Support regulatory agency interactions and negotiations.
Ensure consistency between core and local market labeling.
Monitor external regulatory environment and competitor labeling trends.
May lead or participate in process improvement initiatives.
Mentor and guide junior team members.
Required Qualifications
Advanced degree (PharmD, PhD, MD, or MSc) in life sciences, pharmacy, or a medically related field.
Minimum 10 years of experience in the pharmaceutical or biotechnology industry.
5-6 years in regulatory affairs with significant experience in labeling strategy.
Experience with investigational and marketed products across multiple regions (US, EU required).
Proven involvement in early development labeling strategy.
Preferred Qualifications
Experience incorporating patient-focused evidence into labeling strategy.
Prior experience managing or mentoring team members.
Benefits & Perks
High-quality healthcare.Prevention and wellness programs.At least 14 weeks’ gender-neutral parental leave.