CMC Manager - Regulatory Affairs
Our client is a growing and successful business comprises over 700 talented individuals globally, in an environment where everybody counts and is instrumental to success. With state-of-the-art manufacturing and clinical facilities in the UK and USA, they deliver a full range of drug development solutions around the globe saving their clients both time and money.
We have a new opportunity for a CMC Manager to join their growing Regulatory Affairs Team. In this role you will be responsible for providing CMC regulatory leadership and strategy across the organisation and to our global customer base across EU and US territories.
Your responsibilities will include:-
- Line management and potential global growth of the CMC Regulatory Group.
- Providing expert advice, strategy and guidance to functional groups and sponsors as required on regulatory CMC aspects of programmes.
- Developing excellent relationships with internal global functional groups and sponsors.
- Authoring and reviewing CMC content of dossiers to ensure it is complete, well-written, and meets all relevant regulatory requirements.
- Proactively managing CMC aspects of multiple programmes including overseeing preparation and submission of CMC dossiers, in conjunction with other internal functions.
- Working with internal groups and sponsors to resolve often complex CMC issues.
- Supporting CMC interactions and response to questions with EU agencies and FDA to ensure acceptance, and approval of regulatory CMC packages in support of clinical trials, marketing applications, variations, and other submissions which present CMC information.
- Keeping abreast of changes in the CMC regulatory environment, by researching and interpreting regulations to provide regulatory guidance to the company's Quality, Manufacturing, Analytical and other relevant groups. Ensuring continued management, development and process improvement of CMC related activities within the organisation in response to agency feedback or changes in the regulatory environment.
You will have a BSc in Pharmaceutical Science, Chemistry or Similar and 5 years experience in a CMC focused regulatory affairs role within the Pharmaceutical industry, a sound knowledge and understanding of EU and US CMC regulatory frameworks and experience within drug development in authoring and reviewing CMC related documentations. You should expect to travel frequently between UK and US and have a strong customer focus.
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