Associate Director of Regulatory Affairs
Job Summary
To support the development of innovative cancer therapies, the remote Associate Director of Regulatory Affairs will be responsible for developing and implementing regulatory strategies, leading the Product Regulatory Sub team, and ensuring compliance with global regulatory requirements for assigned products.
Key Responsibilities:
- Ensure the development and execution of regulatory strategies for assigned products/projects
- Represent the company to regulatory health authorities and lead the preparation of submissions, including INDs and Marketing Applications
- Maintain knowledge of the global regulatory environment and implement new processes to improve efficiency
Required Qualifications:
- Bachelor's degree in a scientific discipline; advanced degree (PharmD, Ph.D, MD) preferred
- 8+ years of pharmaceutical industry experience, including 5+ years in Regulatory Affairs leadership roles
- Experience with drug development in the US and EU/UK/EEA; experience in Asia PAC is a plus
- Proven experience in strategic leadership roles with strong project management skills
- Regulatory Affairs Certification is highly desirable
Complete Job Description
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