Job Reference: J5633039
Updated On: 19/03/2020
Status: Now Interviewing
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Role OverviewWe are currently looking for a Global Regulatory CMC Manager to join a leading Biopharmaceutical company based in the Berkshire area. As the Global Regulatory CMC Manager you will be responsible for CMC related activities to support the Life Cycle maintenance of Biological products including pre-MAA submissions.
This is a fantastic opportunity for a developing Regulatory professional, currently at Associate or Senior Associate level, with experience of authoring CMC sections for small or large molecule products to join a leading Biopharmaceutical company and gain global market exposure as well as increased duties and responsibility.
Key Duties and ResponsibilitiesYour duties as the Global Regulatory CMC Manager will be varied however the key duties and responsibilities are as follows:
1. Develop and implement CMC regulatory strategy and submission plans for assigned regional projects in-line with Global strategy.
2. Take a hands-on role in the management of CMC projects including the authoring reviewing and submission of CMC documentation of CTAs, MAAs, BLAs, Variations and Renewals.
3. Sit-on and support Global Regulatory project teams and work cross functionally with Quality and Technical teams to ensure the compliant completion of CMC documentation.
4. Support the Global Regulatory CMC Lead with projects including interactions with Health Authorities.
Role RequirementsTo be successful in your application to this exciting opportunity as the Global Regulatory CMC Manager we are looking to identify the following on your profile and past history:
1. Relevant degree in a life sciences discipline (e.g. Biology, Chemistry, Pharmacology, Regulatory Affairs etc.) in addition to experience of authoring CMC documentation (module 3 sections) for Regulatory filings.
2. Proven industry experience in a Pharmaceutical Manufacturing setting or solely Regulatory CMC experience would be sufficient for this role
3. A working knowledge and practical experience with authoring and contribution to delivering CMC sections of regulatory submissions is vital for this application.
Key Words: Regulatory Affairs | Regulatory CMC | Module 3 | MAA | BLA | NDA | Variations | Renewals | Manufacturing | Biologics | Pharmaceutical | Biopharmaceutical |
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