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Senior Manager, Regulatory Science
A company is looking for a Senior Manager, Regulatory Science Late-Stage Programs. Key Responsibilities Manage regulatory submissions and project management for biologics and Advanced Therapy Medicinal Products (ATMPs) Lead preparation for major health authority interactions and regulatory filings Oversee life cycle management activities in compliance with EU/UK and global regulations Required Qualifications Minimum of 7 years of regulatory experience in biologics and/or ATMPs Strong knowledge of EMA, EU/UK national and global drug development regulations Experience in writing and reviewing regulatory filings (e.g., CTA, IND, MAA, BLA) Educational background: M.S./M.Sc, Pharm. D. or PhD in a relevant scientific field Experience with Gene Therapy Medicinal Products development is a plus
A company is looking for a Senior Manager, Regulatory Science Late-Stage Programs.
Key Responsibilities
Manage regulatory submissions and project management for biologics and Advanced Therapy Medicinal Products (ATMPs)
Lead preparation for major health authority interactions and regulatory filings
Oversee life cycle management activities in compliance with EU/UK and global regulations
Required Qualifications
Minimum of 7 years of regulatory experience in biologics and/or ATMPs
Strong knowledge of EMA, EU/UK national and global drug development regulations
Experience in writing and reviewing regulatory filings (e.g., CTA, IND, MAA, BLA)
Educational background: M.S./M.Sc, Pharm. D. or PhD in a relevant scientific field
Experience with Gene Therapy Medicinal Products development is a plus