Regulatory Cmc Strategist
2 months ago
Proclinical are recruiting a Regulatory CMC Strategist for an organisation. This role is on a contract basis with the ability to work remotely.
**Responsibilities**:
- You will interface with a company associate office for particular methods or actions that impact a specific location.
- Evaluate the preparation of both M2 and 3 CMC components of archiving and examine fitness of purpose for proposal in the pertinent countries.
- Write and arrange responses to queries across allocated products and countries.
- Discuss regional requirements for guaranteeing reliability of the supply chain as well as successful launch is outlines and executed in cooperation with pertinent regional shareholders.
- Offer leadership for regulatory examinations of change control requests.
- Collect, consolidate and analyse regulatory intelligence for global markets and assist with its implementation to product-specific actions.
- Uphold a consciousness of new and developing legislation, regulatory policy and technical Regulatory direction linking to company products.
- Other duties may be assigned to this role.
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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Regulatory
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