Reference Number: JO-2208-498312
Regulatory Affairs Manager
Rate: Negotiable
Job Type: Permanent
Location: Walton-On-Thames

Regulatory Affairs Manager

6 month contract

CMC – biologics focused

Offering up to 43.50 Per Hour PAYE

Remote working

CPL Life Sciences is collaborating with a leading pharmaceutical firm who is looking for a Regulatory Affairs Manager with a background in CMC and biologics to join their established team. Within this role you will be responsible for supporting one or more regional products generating country specific regulatory strategies.

Job Responsibilities include;

Ensuring CMC regional issues impacting global regulatory strategy for proposed CMC filings are considered and risks identified with appropriate contingency strategies

Review the preparation of M2 and 3 CMC components of filings and assess fitness of purpose for submission in the relevant countries

Manages strategy and execution for all regulatory CMC submissions

Gathering, consolidating and analyzing regulatory intelligence for International Markets and supports its application to product-specific activities

Candidate Requirement Include;

Must be eligible to live and work in the United Kingdom

Life Science degree or equivalent

Previous CMC biologics experience

Able to demonstrate ability to work on undefined projects and ability to adapt with clients changing needs

If this role of interest to yourself please forward your CV to sophie.malyon@cpl.com.

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