Associate Director, Regulatory Affairs, Cmc

AskBio Inc.

Research Triangle Park, North Carolina, United States
8+ years cmc drug development experience
3+ years regulatory affairs cmc role
Ind/cta and nda/bla/maa submission record
The company is dedicated to developing life-saving gene therapy medicines for neuromuscular, CNS, cardiovascular, and metabolic diseases

Job Summary

  • The company is dedicated to developing life-saving gene therapy medicines for neuromuscular, CNS, cardiovascular, and metabolic diseases.
  • This role involves managing the regulatory CMC strategy and coordinating activities to ensure timely global registration of product candidates.
  • The position requires driving the preparation and submission of high-quality CMC sections for INDs, BLAs, and other critical filings.

Matching Summary

The company is dedicated to developing life-saving gene therapy medicines for neuromuscular, CNS, cardiovascular, and metabolic diseases.

Skills & Requirements

Must-have

  • 8+ years CMC drug development experience
  • 3+ years Regulatory Affairs CMC role
  • IND/CTA and NDA/BLA/MAA submission record
  • Gene therapy product development knowledge
  • US and international regulatory compliance

Nice-to-have

  • Advanced degree in scientific discipline
  • Experience with Veeva Electronic Document Management
  • Strong negotiation and communication skills
  • Knowledge of FDA, EMA, MHRA regulations
  • Bias for learning and action

Key Requirements

  • Bachelor's degree in science or engineering
  • Minimum 8 years CMC drug development experience
  • At least 3 years in Regulatory Affairs CMC
  • Proven track record of successful regulatory submissions

Work Rights

Not specified

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