Job Reference: J5631851
Updated On: 12/07/2019
Status: Open to Applications
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Regulatory CMC Manager
We are currently looking for a Regulatory CMC Manager to join a leading Regulatory Consultancy based in the Hertfordshire area. As the Regulatory CMC Manager you will offer internal and external clients expert CMC Regulatory advice on a range of Biological programmes. You will use your understanding of Regulatory processes as well as your knowledge of Biological Manufacturing to ensure successful submissions for products at development stage.
Key Duties and ResponsibilitiesYour duties as the Regulatory CMC Manager will be varied however the key duties and responsibilities are as follows:
1. Provide expert CMC advice to clients developing a wide range of Biological products including Cell and Gene Therapy products.
2. You will author the CMC sections of IMPDs and INDs to EU regulatory procedures as well as assisting with the development of strategies for submission.
3. Be the regulatory lead and main point of contact for national agencies and EMA interactions on all CMC activities.
4. Advise global clinical development teams in the requirements for EU based programmes, and to integrate with other regional experts.
Role RequirementsTo be successful in your application to this exciting opportunity as the 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, Biochemistry, Chemistry, Drug Development etc.) in addition to hands on experience in a Regulatory CMC focused role.
2. Proven industry experience of writing IMPD's and IND's, attending Scientific Advice meetings as well as liaising and negotiating with Regulatory Authorities.
3. A working knowledge and practical experience with EU regulatory procedures. FDA exposure would be a benefit to your applications.
Key Words: Regulatory Affairs | CMC | Biologics | Pharmaceuticals | IMPD | IND | EMA | FDA | Manufacturing | Scientific Advice
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