Regulatory Cmc Strategist - Surrey, United Kingdom - Proclinical

Proclinical

Verified Company

Surrey, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

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 productspecific 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.

LI-PD1

Regulatory