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Regulatory Affairs CMC Consultant
- Contract
- CMC
- United Kingdom
Proclinical are recruiting for a Regulatory Affairs CMC Consultant to join an organisation. This role is on a contract basis with the ability to work remotely from anywhere in the UK.
Responsibilities:
- Conduct regulatory research to obtain pertinent histories, precedence and any other information pertinent to regional product advancement.
- Write and arrange replies to queries across allocated products and countries.
- Guarantee CMC regional concerns affect international regulatory method for suggested CMC filings are considered and risks recognised with suitable contingency methods.
- Evaluate the preparation of M2 and 3 CMC factors of filings and examine fitness of purpose for proposal within the pertinent countries.
- Offer direction for regulatory examinations of change control requests.
- You will share regulatory information and implications with shareholders on an ongoing basis and offer advice on regional considerations.
- Other duties may be assigned.
If you are having difficulty in applying or if you have any questions, please contact Peter Duvall on p.duvall@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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