Cpl Life Sciences – Regulatory

Operations Regulatory CMC Associate

23 Feb 2021
24 Mar 2021
Sophie Malyon
Regulatory Affairs, CMC
Full Time
Contract Type
Experience Level
Experienced (non-manager)

Regulatory Operations CMC Associate
12 month contract
Remote based working presently with long term office based in Macclesfield
Offering up to 15.00 Per Hour PAYE
ASAP start

CPL Life Sciences is collaborating with a leading pharmaceutical organisation that is actively seeking a Regulatory Operations CMC Associate on an initial 12 month contract basis. This is a perfect opportunity for a recent graduate or individual that has completed an internship within Regulatory.

Working with the Regulatory CMC team you will be responsible for supporting the production and regulatory submission of CMC documentation for commercial products across the product lifecycle.

Job Responsibilities include;

Coordinate the assembly, including document requests and generation, of submission-ready components to support lifecycle submissions linked to license maintenance and post approval changes
Support the timely delivery and submission of post approval CMC documentation to marketing companies and health authorities
Review and approve regulatory CMC documents on behalf of Operations Regulatory
Maintenance of electronic systems to ensure the current regulatory submission and commitment status is accurately reflected, notifying relevant departments and groups of health authority approvals as they are received

Candidate Requirements include;
Must be eligible to live and work in the United Kingdom
Graduate in a scientific discipline
Excellent written and spoken English
Any prior understanding of the drug development process and regulatory submissions is highly desirable

If this opportunity if of interest to yourself please call Sophie at CPL Life Sciences on 07526 003 117 or alternatively email your up to date CV to sophie.malyon@cpl.com.

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