Director, Regulatory Affairs
BeOne Medicines
Full-time
Remote friendly (United States)
Worldwide
$171,300 - $231,300 USD yearly
Other
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Director, Regulatory Affairs
Company Name
BeOne Medicines
Job Overview
The Director, Regulatory Affairs will develop, implement, and advise on North America (NA) regulatory strategies for development programs to secure and maintain market access. This role manages NA regulatory aspects through all development phases, post-approval, and product lifecycle. The incumbent will provide leadership and strategic regulatory oversight from a NA perspective, interfacing with agencies like the FDA and Health Canada, and business partners.
Responsibilities
- Develop regulatory strategies
- Oversee submissions
- Liaise with health authorities
- Manage regulatory teams
Requirements
- 10+ years in biotech/pharma
- 5+ years in regulatory affairs
- Bachelor's degree