Overview

Reference Number: JO-2401-527941
Regulatory Affairs Manager
Rate: Negotiable
Job Type: Permanent
Location: Macclesfield

Regulatory Affairs Manager

12 month contract 

Cheshire based – flexible working 

Inside IR35

Offering up to £45.00 Per Hour via PAYE

ASAP start  

Do you have a background in Regulatory CMC? Are you open to discussing new opportunities with a Top 10 Pharma? If so I could have the role for you! 

CPL have partnered with a leading pharmaceutical company who are looking for two Regulatory Affairs Managers to join their established teams in Cheshire. Working on their second largest manufacturing site you will be responsible for global CMC regulatory activities across the global supply chain. Initially on a 12 month contract, hybrid office based working is on offer. As a CMC Regulatory Manager you will be a leading contributor to regulatory CMC components across multiple projects. 

Job Responsibilities include; 

– Manage the production of Chemistry, Manufacturing and Control (CMC) documentation for designated product ranges 

-Manage global CMC regulatory submissions ensuring that project activities and documentation are delivered to the required standards across the product lifecycle including keeping business wide electronic systems up to date to maintain regulatory status.

– Interactive communication with stakeholders, collaborators, and project team members to ensure that relevant timelines and regulatory commitments are communicated.

Candidate Requirements include;

– Eligibility to live and work in the United Kingdom

– Life Sciences degree or equivalent background 

– Must be fluent in spoken and written English

– Prior Regulatory CMC experience with the understanding of Regulatory CMC dossiers and requirements

– High level understanding of GMP and working in a regulated environment

If this position is of interest to yourself please email your CV to sophie.malyon@cpl.com for more information.

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