Overview

Reference Number: JO-2010-456438
Regulatory CMC Analyst
Rate: Negotiable
Job Type: Contract
Location: Macclesfield

Regulatory CMC Analyst
12 month contract
Macclesfield based (Home working flexibility initially)
Offering up to 17.00 Per Hour DOE

Clinical Professionals is working on behalf of an innovative pharmaceutical organisation who are seeking a Regulatory CMC Analyst on a 12 month contract basis. This position is ideal if you are a recent graduate with a scientific degree or have recently completed a placement year within regulatory. With the client currently operating remote based working the expectation in the long term is the contract will be completed from their Macclesfield offices.

Job Requirements include;
– Produce and support the production and regulatory submission of Chemistry, Manufacturing and Control (CMC) documentation for commercial products at various stages of the product life-cycle, in the required format and to the agreed timetable
– 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;
– Individual must be eligible to live and work in the United Kingdom
– Life Sciences degree or equivalent
– Previous experience working in a pharmaceutical regulatory setting or completed a placement year would be highly advantageous
– Documentation management experience would be a significant advantage along with knowledge of systems such as Angel or Trackwise

If this position is of interest to yourself please forward your CV to sophie@regulatoryprofessionals.com.

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