Director, Global Regulatory Affairs – Global Labeling Strategy
Sanofi
Cambridge, MA
15 days ago
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Job Description
Join Sanofi as the Director of Global Regulatory Affairs, where you'll lead the global labeling strategy for innovative medicines. Your expertise will ensure compliance with regulatory requirements and enhance patient care through strategic labeling initiatives. Embrace the chance to make a significant impact in the healthcare industry.
Key Responsibilities
Lead the development and alignment of global labeling strategy and content
Provide regulatory labeling leadership to cross-functional teams
Contribute to early development programs with strategic input
Assess opportunities for patient experience data integration
Represent Global Labeling in 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 trends
Participate in process improvement initiatives
Mentor and guide junior team members
Required Qualifications
Strong knowledge of global regulatory labeling requirements (FDA, EMA, ICH)
Strategic thinking and ability to influence regulatory direction
Scientific rigor and analytical ability to interpret complex data
Proven leadership and collaboration skills
Excellent communication and stakeholder management skills
Project and time management expertise
Strong understanding of regulatory submission processes
Preferred Qualifications
Advanced degree (PharmD, PhD, MD, or MSc) in life sciences
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
Proven involvement in early development labeling strategy
Experience incorporating patient-focused evidence into labeling strategy
Prior experience managing or mentoring team members
Benefits & Perks
High-quality healthcarePrevention and wellness programsAt least 14 weeks’ gender-neutral parental leave