Full-Time Associate Director, Regulatory Affairs
Deciphera Pharmaceuticals is hiring a remote Full-Time Associate Director, Regulatory Affairs. The career level for this job opening is Manager and is accepting Waltham, MA based applicants remotely. Read complete job description before applying.
Deciphera Pharmaceuticals
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The Associate Director, Regulatory Affairs will join a group of highly motivated, top-notch regulatory professionals and will be a key player in shaping cohesive regulatory strategies across the product pipeline. This role provides regulatory support for oncology products in early-stage and late-stage development through post-approval.
The Associate Director is responsible for:
- Develop regulatory strategies for oncology development programs
- Provide solid regulatory solutions and guidance to cross-functional teams and senior management
- Monitor global regulatory changes that may impact asset development
- Ensure compliance of regulatory strategies and submissions
Requirements:
- B.S/M.S. and 10+ years of work experience in pharmaceutical regulatory affairs
- 5+ years of regulatory experience working with global development and submission plans
- Advanced knowledge and experience in interpretation of regulations, guidelines, and precedents related to oncology drug development in the US and EU
- Experience filing INDs and/or NDAs and engagement with FDA and other regulatory bodies