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CMC Regulatory Affairs Consultant

CK Group- Science, Clinical and Technical
Posted 5 days ago, valid for 19 hours
Location

High Wycombe, Buckinghamshire HP13 6LE, England

Salary

£45 - £62.93 per hour

Contract type

Full Time

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Sonic Summary

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  • CK Group is seeking a CMC Regulatory Affairs Consultant for a 6-month contract in High Wycombe within the Pharmaceutical industry.
  • The salary ranges from £45.00 to £62.93 per hour PAYE or £65.00 to £84.55 per hour Umbrella.
  • The role involves developing CMC regulatory strategies across EMEA and leading a Regulatory Affairs team for product registrations.
  • Candidates should have a relevant Bachelor's Degree or equivalent experience in pharmaceutical CMC regulatory affairs, along with expertise in drugs, dietary supplements, and medical devices.
  • Strong project management skills and knowledge of EU/EMEA regulatory frameworks are essential for this position.
CK Group are recruiting for a CMC Regulatory Affairs Consultant, to join a company in the Pharmaceutical industry, at their site based in High Wycombe, on a contract basis for 6 months.


Salary:

45.00 - 62.93 per hour PAYE or 65.00 - 84.55 per hour Umbrella.


CMC Regulatory Affairs Consultant Role:
  • Responsible for the development of CMC/technical regulatory strategies across the EMEA.
  • Leads a Regulatory Affairs team ensuring the success of new product registrations, line extensions and new indications and claims.
  • Manages the global or regional regulatory deliverables for drugs, dietary supplements & medical devices as relevant.
  • Develops strong partnerships with Regulatory Affairs Franchise, R&D, Marketing, Supply Chain & local business representatives.
  • Represents the Regulatory Affairs CMC function as appropriate in Self Care Franchise, functional & business Leadership teams.

Your Background
:
  • Relevant Bachelor's Degree or equivalent work experience inpharmaceutical CMC regulatory affairs.
  • Expertise across a broad spectrum of Regulatory classifications including Drugs, Dietary Supplement and/or Medical Devices.
  • Knowledge of regulatory frameworks and external environments in the EU/EMEA , & the ability to apply these to regulatory solutions throughout the product lifecycle.
  • Solid understanding of regulatory CMC in the markets of relevance.
  • Strong project management skills.

Company:

Our client is the largest and most broadly-based healthcare company. They strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere.


Location:

This role is based at our clients site in High Wycombe. This is a hybrid role with 2-3 days expected on site.


Apply:

It is essential that applicants hold entitlement to work in the UK. Please quote job reference (Apply online only).


Please note:


This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.


If this position isn't suitable but you are looking for a new role, or if you are interested in seeing what opportunities are out there, head over to our LinkedIn page (cka-group) and follow us to see our latest jobs and company news.

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By applying, a CV-Library account will be created for you. CV-Library's Terms & Conditions and Privacy Policy will apply.