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Pioneering science to create transformative molecular medicines.
Associate Director, Regulatory Affairs, CMC
Location
United States
Posted
66 days ago
Salary
0
Seniority
Senior
Job Description
Associate Director, Regulatory Affairs, CMC
Asklepios BioPharmaceutical, Inc. (AskBio)
• Manage the regulatory CMC strategy and coordinate regulatory activities for all assigned projects • Ensure appropriate development and timely registration of gene therapy product candidates • Drive the preparation and submission of high‑quality CMC sections of regulatory filings • Collaborate closely with CMC, Quality, and external partners • Support innovative regulatory CMC strategies and timelines
Job Requirements
- Bachelor’s degree in a scientific or engineering discipline
- 8+ years of experience in CMC drug development
- At least 3 years in a Regulatory Affairs CMC role
- Proven record of contributions to successful IND/CTA and NDA/BLA/MAA submissions and approvals
- Extensive experience compiling investigational submissions such as US INDs, US IND amendments, Canadian CTA’s, IMPDs and other international submissions
Benefits
- Opportunity for Secondment
- Unique chance to broaden your experience
- Contribute meaningfully to AskBio’s mission
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