CMC Regulatory Affairs Consultant

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 in pharmaceutical 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 .


Please note:

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

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