Regulatory Affairs Specialist managing regulatory documentation for a European pharmaceutical company. Ensuring compliance with health authorities and supporting product lifecycle management in a hybrid model.
About the role
- Regulatory Affairs CMC Project Lead coordinating multiple pharmaceutical projects at Sanofi. Providing strategic regulatory guidance, mentoring team members, and ensuring compliance in drug development.
Responsibilities
- Serve as a strategic regulatory expert coordinating multiple cross-functional projects
- Provide senior-level CMC regulatory guidance and mentor team members
- Drive accountability for deliverables and influence decision-making
- Ensure regulatory compliance and alignment with Sanofi's values
- Leverage AI and digital platforms to accelerate development timelines
Requirements
- Minimum 6+ years of CMC regulatory strategy experience
- Experience guiding or mentoring junior staff
- Strong knowledge of CMC regulatory requirements in major markets
- Good understanding of pharmaceutical development and manufacturing processes
- Effective communication and influencing abilities
- Ability to coordinate multiple projects simultaneously
- B.S. or M.S. degree in a scientific discipline
- Fluency in English (written and spoken)
Benefits
- High-quality healthcare
- Prevention and wellness programs
- At least 14 weeks’ gender-neutral parental leave
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