Job Summary
A biotechnology company has a current position open for a Remote Global Regulatory Lead CMC Associate Director.
Must be able to:
- Identify supporting documents required for global submissions
- Participate in skill development and coaching of other Global RegCMC Team members as required
- Accountable for the coordination and overall global approval of regulatory assessments for CMC changes
Position Requirements Include:
- BS degree in Life Sciences, Engineering, Biotechnology, or relevant Pharmaceutical Science
- At least 7+ years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity
- Extensive experience of direct communication and negotiation with regulatory agencies on CMC topics
- 5+ years of experience in Regulatory CMC (Commercial)
- Broad background of registration experience gained from working in the pharmaceutical industry
- Knowledge of global guidance, regulations and ICH/GMP requirements
