CMC, Senior Regulatory Manager - 12 month contract

An excellent opportunity has arisen for an experienced CMC Professional to join a leading Pharmaceutical company based in West London.

Within this role you will be responsible for CMC activities across Europe, Middle East and Africa.

This is a 12 month contract with the possibility of extension - £50.00 per hour.



Responsibilities:



, Perform CMC gap analysis comparing registered dossiers with current manufacturing site practice
, Compare the batch manufacturing records, product specification, analytical methods used to that what is registered in the MA
, Check the variation history on changes registered
, Check on raw material grades and suppliers used in the MA (manufacturing)
, Compile the gap analysis in a template
, Identify the required documentation for CMC submissions and negotiate the delivery of approved technical source data and documents in accordance with project timelines
, Prepare and review CMC responses to health authority questions during development, registration and product lifecycle
, Work with R&D, Quality and other regulatory colleagues to ensure documentation meets EMEA CMC regulatory requirements
, Write high-quality CMC documents to support product maintenance activities
, Provide advice on CMC regulatory strategies
, Create supporting documentation to ensure successful product lifecycle management

Experience Required:

, The ideal candidate will be a regulatory affairs professional with significant CMC experience
, Life sciences degree, or equivalent
, Hands-on European regulatory activities within a pharmaceutical company (including 7+ years CMC regulatory experience)
, Excellent interpersonal, verbal and written skills and have the ability to provide CMC regulatory support to different functional areas (e.g., Quality, R&D, Supply Chain) as required.



For further details about this role or for a confidential chat about other roles within Regulatory Affairs please Tim Barratt on +44 (0)1727 817 626 or email me a copy of your CV to tbarratt@keypeople.co.uk


  • Start: a.s.a.p
  • Duration: 12 months
  • Location: City of London, England
  • Type: Contract
  • Industry: Pharmaceutical
  • Recruiter: Key People
  • Tel: +44 (0)1727 817 626
  • Fax: 01727 844 838
  • Email: to view click here
  • Posted: 2020-10-12 16:20:12 -

  • View all Jobs from Key People


Share Job