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Director / Senior Director, Regulatory Affairs CMC
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- The Senior Director, Regulatory Affairs CMC will be responsible for planning and executing the CMC regulatory strategies for Celldexs therapeutic development programs.
- This position will manage processes that are required to plan and execute CMC regulatory strategies.
- Plan CMC regulatory strategies: define regulatory pathways and milestones for submissions to support development activities leading to successful study authorizations and ultimately global BLA approvals.
- Align CMC regulatory plans with cross-functional development and manufacturing teams
- Articulates complex CMC regulatory issues to project teams and external stakeholders to support global development and commercialization of drug candidates
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