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Regulatory CMC Associate Posted Jul 14
Hays Resource Management - Astrazeneca , Macclesfield, Cheshire, United Kingdom
 
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Regulatory CMC Associate

Location: Macclesfield

Contract duration: 12 months

Remuneration: Competitive hourly rate

Regulatory CMC Associate are required to produce and support the production of Chemistry, Manufacturing and Control (CMC) documentation for designated commercial products at various stages of product life cycle, in the required format and to the agreed timetable.

The Regulatory CMC Associate is responsible for:

Providing CMC regulatory and compliance advice on regulatory post-approval submissions

Working cooperatively with stakeholders across CMC Regulatory Compliance, Global Regulatory Affairs and Operations

Supporting the timely submission of post approval CMC documentation

Coordinating assembly and/or generate documentation of submission-ready components to support life cycle submissions

Review and approval of regulatory CMC documents on behalf of CMC Regulatory Compliance

Support cross-functional approval for delivery of the documentation to Global Regulatory Affairs for worldwide use in regulatory submissions

Notify manufacturing sites of health authority approvals

Updating all relevant electronic systems to be consistent with regulatory submissions and commitments.

Skills Required:

Graduate in a scientific discipline eg chemistry, pharmacy or biological science

Basic knowledge of the drug development process and regulatory submissions

Experience in Pharmaceutical Production, Regulatory Affairs, Quality Assurance, R&D

Understanding of current regulatory CMC requirements

This position would be suitable for a recent graduate

Hays Talent Solutions is a trading division of Hays Specialist Recruitment Limited and acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers. By applying for this job you accept the T&C's, Privacy Policy and Disclaimers which can be found on our website.

Employment Type: Contract
Duration: 12 months

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