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Regulatory CMC Manager
A company is looking for a Manager, Regulatory CMC. Key Responsibilities Oversee regulatory CMC activities for biologics and Advanced Therapy Medicinal Products (ATMPs) Write and review Module 3/QOS sections and prepare agency meeting materials Manage regulatory activities across the product lifecycle in the US, EU, and UK Required Qualifications Minimum 3 years of regulatory CMC experience with biologics and/or ATMPs Experience with gene therapy medicinal products is a plus Broad experience across the product lifecycle is advantageous M.S./M.Sc, Pharm. D. or PhD in a relevant scientific field Experience in regulatory activities in US, EU, and UK
A company is looking for a Manager, Regulatory CMC.
Key Responsibilities
Oversee regulatory CMC activities for biologics and Advanced Therapy Medicinal Products (ATMPs)
Write and review Module 3/QOS sections and prepare agency meeting materials
Manage regulatory activities across the product lifecycle in the US, EU, and UK
Required Qualifications
Minimum 3 years of regulatory CMC experience with biologics and/or ATMPs
Experience with gene therapy medicinal products is a plus
Broad experience across the product lifecycle is advantageous
M.S./M.Sc, Pharm. D. or PhD in a relevant scientific field
Experience in regulatory activities in US, EU, and UK
