Regulatory CMC Manager
Proclinical are recruiting for a Regulatory CMC Manager to join a pharmaceutical organisation. This role is on a contract basis and is located in the UK.
- Accountable for producing country specific regulatory methods as well as offer feedback to internal teams concerning proposal plans and implementation of the method for one or more products.
- Offer leadership on regulatory assessments of change control requests.
- You will share regulatory information and executions with the shareholders on an ongoing basis and offer advice on regional considerations.
- Uphold consciousness of both new and evolving legislation, regulatory policy and technical regulatory guidance connected to the company's products.
- Evaluate the preparation of both M2 and 3 CMC components of archiving and examine fitness of purpose for proposal within the pertinent countries.
- Write and arrange replies to queries across allocated products and countries.
- Discuss regional necessities for guaranteeing dependability of the supply chain and successful launch are well outlined and executed in cooperation with pertinent regional shareholders.
If you are having difficulty in applying or if you have any questions, please contact Dracen Black at firstname.lastname@example.org.
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.