Manager, Regulatory Affairs coordinating global regulatory submissions for therapeutic development. Collaborating cross - functionally to meet regulatory agency requirements and ensure compliance.
About the role
- Global Regulatory Affairs Device Lead developing regulatory strategies for medical devices and combination products at Sanofi. Collaborating with cross-functional teams to ensure compliance and optimize approval pathways.
Responsibilities
- Serve as GRA Device Lead on assigned project teams
- Provide regulatory guidance and advice to Global Regulatory Team and cross-functional teams
- Develop and execute innovative and sustainable medical device regulatory strategies
- Lead global filing and lifecycle management activities for device submissions/device aspects of medicinal product submissions
- Liaise with device, clinical, manufacturing, commercial, and other internal business partners to enable successful regulatory outcomes
- Prepare, review, and approve design control deliverables
- Ensure appropriate communication, resolution, and/or escalation of issues
Requirements
- 8+ years of relevant pharmaceutical/biotechnology/medical device industry experience
- 5+ years of medical device and/or combination product regulatory experience
- Experience in large organizations
- Familiarity with international submissions from within a global healthcare organization
- Bachelor's degree in a scientific or engineering discipline; graduate degree preferred
- Strong written and verbal communication skills, fluent in English
- Ability to manage multiple projects in a fast-paced, hybrid work environment
Benefits
- Health insurance
- 401(k) matching
- Flexible working hours
- Paid time off
- Remote work options
- At least 14 weeks gender-neutral parental leave
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