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Associate Director / Director, CMC Dossier Management
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Full-time
- Plays a critical role in ensuring that the CMC submission strategy is aligned closely with the clinical/regulatory development strategy and provide drug development experience and advice to the CMC team.
- Will lead CMC Coordination activities for later stage and more complex projects, anticipate regulatory questions, and help drive first pass approvals Responsibilities Author and coordinate submission documentation for all phases of clinical development, with emphasis on later phase programs and marketing applications, often under significant time pressure.
- Leverage extensive drug development experience to lead the global cross-functional CMC Team in completion of global regulatory submission documents.
- Manages completion of CMC regulatory submission documentation for multiple projects of moderate complexity utilizing a matrix management approach.
- Serve as the primary Drug Product Development (DPD) representative to interface with the CMC Regulatory group.
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