Job Reference: J5630785
Updated On: 18/01/2019
Status: Now Interviewing
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Role OverviewA fantastic opportunity for a Regulatory CMC Manager has opened within a rapidly growing Cell and Gene Therapy company based in the Hertfordshire area. As the CMC Regulatory Manager you will develop the company's CMC regulatory strategy to ensure the successful development of life changing ATMP medicinal products.
Key Duties and ResponsibilitiesYour duties as the Regulatory CMC Manager will be varied however the key duties and responsibilities are as follows:
1. You will shape the CMC regulatory Strategy and use your extensive CMC experience to identify potential Regulatory challenges.
2. You will lead the preparation of CMC regulatory documentation ensuring timelines are maintained and aligned with the rest of the regulatory team.
3. You will offer CMC regulatory guidance to the scientific staff and key stakeholders within the company and co-ordinate CMC focused meeting with regulatory agencies.
4. You will write CMC Regulatory documentation including but not limited to CMC question responses, CMC Scientific Advice briefing packages, Modules 2 and 3, PIP / PSP, PRIME and RMAT.
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, Biotechnology, Pharmacy, Pharmacology etc.) in addition to extensive CMC understanding and knowledge.
2. Proven industry experience in a CMC Regulatory setting, ideally within a Biotechnology, Biologics or Biopharmaceutical industry. This includes leading and advising on CMC regulatory strategy as well as hands on experience with CMC documentation writing.
3. A working knowledge and practical experience with Advanced Therapies would be a benefit to your application. Rare disease experience or novel therapeutic platform development is desirable.
Key Words: CMC | Regulatory Affairs | CMC Manager | Module 3 | Biologics | ATMP | Rare Disease | Gene Therapy | AAV vectors | CMC Documentation
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