Senior Manager/Associate Director Regulatory Affairs
My client is a clinical stage biotech company which develops innovative protein therapies to treat various forms of cancer. They are rated as one of the top biotech companies in their space, with the largest library of molecules of any other company. They are in search of a Senior Manager/Associate Director of Regulatory Affairs to be the “captain” of their gastric cancer regulatory team. This is an exceptional opportunity where you can take the reins and lead a novel program currently in Phase IB and heading into Phase II. This position reports to the Executive Director of Regulatory and offers room to advance with a growing company. The ideal professional is someone who works well in a scientific driven, collaborative environment.
Responsibilities:
- Develop and implement strategies to facilitate the progress of Phase I through Phase III clinical development programs
- Plan regulatory milestones over the product lifecycle in coordination with cross-functional interdependencies
- Serve as regulatory representative for select product development programs, including regulatory liaison with business partner(s), the FDA and other regulatory agencies
- Lead cross-functional team to develop complex regulatory submissions.
- Review technical reports and summary documents (clinical, pharmacology, CMC) for adherence to regulatory guidelines, strategies, and commitments
- Manage internal personnel and activities of external contractors
- Develop individual talent and coach others to produce results
Knowledge and Skills:
- Minimum BS required, advanced scientific degree preferred
- Minimum 10 years’ industry experience with a minimum of 7 years spent in a regulatory environment
- Must have oncology regulatory experience
- Must have experience working with the cross functional team in a strategic way
- Experience in managing major regulatory filing(s) such as IND or NDA marketing applications; CMC and/or companion diagnostic experience is a plus
- Extensive knowledge of FDA regulations, practices and ICH guidances
- Must be able to identify and resolve issues in a timely manner
- Must have well written and communication skills