Associate Director, Regulatory Affairs
BeOne Medicines(1 month ago)
About this role
The Associate Director, Regulatory Affairs at BeOne leads North America regulatory strategy and oversight for development programs and marketed products, coordinating with global regulatory leadership and internal stakeholders. The role interfaces with regulatory agencies (FDA and Health Canada) and business partners to secure and maintain market access across product lifecycle stages. The position also provides people leadership and contributes to department policy and process development.
Required Skills
- Regulatory Strategy
- Regulatory Submissions
- FDA Interactions
- Health Canada
- IND/CTA
- NDA/BLA
- Lifecycle Management
- Team Leadership
- Veeva
- Clinical Trials
+4 more
Qualifications
- Bachelor's Degree
- Advanced Degree Preferred
About BeOne Medicines
beonemedicines.comBeOne Medicines, formerly BeiGene, is committed to developing innovative cancer medicines by partnering globally to serve patients everywhere.
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