Head of Global Regulatory Affairs, CMC Small Molecule

• Provides Leadership to their group and is accountable for organizational design, people development, resource allocation, and metrics
• Oversees the development of CMC regulatory strategy and regulatory risk assessments for all development projects and marketed products
• Assures that positive and collaborative relationships are developed with CMC and Device teams
• Oversees strategic negotiations with worldwide Regulatory Agencies, including directly with FDA and EMA
• Oversees the preparation review and approval of Regulatory CMC submissions
• Provides a vision and leadership for Policy and Regulation to assure that appropriate Sanofi representation in external activities is achieved

• Minimum 10-15 years of direct Regulatory CMC experience preferred
• Demonstrated progression in regulatory affairs roles and successful regulatory authority interactions
• Global Leadership experience with a mid-size/large Regulatory CMC organization
• Strong knowledge of key Agency/Industry thinking, trends and regulations / guidelines
• Bachelor's degree required
• Advanced degree (Masters, PhD) in a science or health field (i.e., Analytical, Chemistry, Pharmacy, Biological / Biotechnology Sciences, etc.), or equivalent is highly desirable
• Demonstrated excellent communication and influencing skills internally and externally
• Demonstrated ability to assess regulatory risks, identify opportunities, and develop pragmatic solutions that align with business objectives
• Experience building and maintaining effective partnerships across functions and with external stakeholders, including health authorities
• 20% travel expected, domestic and international

Experience working for a Regulatory Health Authority is helpful but not essential

• High-quality healthcare, prevention and wellness programs
• At least 14 weeks’ gender-neutral parental leave