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... for the development of the CMC regulatory strategy for submissions. These submissions ... IND/CTA, NDA, CTD and MAA regulatory filings. Collaborate with other relevant ... functions to prepare and..
... business results. Job Description: The Associate Director of GPS Business Development and ... the Chemistry, Manufacturing & Controls (CMC) and product supply aspects including ... functions, SME’s and governance..
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... on internal/external system audits and regulatory agency inspections Responsible for business ... documentation system in compliance with regulatory requirements, company requirements and procedures; ... research, analytical, quality, engineering, manufacturing,..
... results. Functional Area Description The GRS-CMC organization provides regulatory expertise related to CMC activities through all stages of ... of the organization develop global regulatory CMC strategies and partners..
... make a difference. Position: Executive Director, Regulatory Affairs Team Leader Supervisor: Vice ... Team Leader Supervisor: Vice President, Regulatory Affairs Department: Global Regulatory Affairs Prerequisites Bachelors in scientific .....
... development strategy and all process-related CMC deliverables across multiple sites including ... implementation, platform process lifecycle strategy, regulatory submissions, and handoff to manufacturing ... with appropriate scale, GMP and..
