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Regulatory Project Manager

Middlesex   •  Contract/Temporary, Full time


CK Group are recruiting for a Regulatory Project Manager to join a company in the healthcare industry at their site based in Brentford initially on an 12 month contract.

Rate:
£374.69 per day PAYE / £489.83 Umbrella per day

Regulatory Project Manager Role:
? Responsible for the regulatory management of clinical assets and MAs for a a portfolio of products for Ireland and UK
? Is the primary interface with the local regulatory authorities
? Ensure product information, Product Characteristics (SPCs) and Patient Information Leaflets (PILs)/ labelling are compliant
? Responsible for the local management of product registration documents in regulatory databases and repositories
? Completes Marketing Authorisation Holder (MAH) review of Periodic Quality Reviews

Your Background:
? Graduate/PhD level or equivalent, with experience in the pharmaceutical industry, including regulatory experience
? In depth understanding and practical experience of national or/and EU regulations, guidelines and working practices and of the regulatory issues relevant to the portfolio.
? Knowledge of drug development process and regulatory affairs
? Knowledge of the commercial and medical issues pertaining to the assigned portfolio, including an awareness of competitor products and activities
? Ability to work in a complex environment with good interpersonal and influencing skills

Ideal candidate:
? Has an understanding of the impact of the regulatory environment and proposed changes which are likely to impact the business in the medium term.
? Can define regulatory strategy
? Has an in-depth understanding of regulatory governance, medical and safety

Company:
Our client is a global healthcare company, taking on some of the world's biggest healthcare challenges.

Location:
This Regulatory Project Manager role is based at our clients site in Brentford, Greater London.

Apply:
For more information, or to apply for this Regulatory Project Manager position please contact the Key Accounts Team on 01438 870011 or email pharmacontracts@ckagroup.co.uk. Please quote reference 52935.

It is essential that applicants hold entitlement to work in the UK.
Please note that the successful applicant will be required to engage via an FCSA-accredited and CK-approved umbrella company and the rate of pay indicated is an umbrella rate.


You must have the right to work in the UK. Learn more

  • Agency: CK Group
  • Reference: 52935
  • Posted: 28th April 2022
  • Expires: 26th May 2022

CK Group

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