Regulatory Project Manager

Location
Brentford
Salary
£563 per day Umbrella
Posted
26 Jul 2021
Closes
25 Aug 2021
Ref
51241
Contact
Julie Marshall
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Contract
Experience Level
Management
CK Group are recruiting for a Regulatory Project Manager to join a company in the healthcare industry at their site based in Brentford on a contract basis for 12 months.

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, London.

Salary:
£563 per day Umbrella.

Regulatory Project Manager Role:
  • Responsible for the regulatory management (delivery and maintenance) of clinical assets and MAs for a portfolio of products for Ireland and UK.
  • You will be the primary interface with the local regulatory authorities.
  • Ensure product information is compliant with MA. Ensures that company product Summary of Product Characteristics (SPCs) and Patient Information Leaflets (PILs)/labelling are compliant with MA and with regulatory requirements.
  • Co-ordinate national input into responses to regulatory questions and regulatory commitments, ensuring these are in alignment with regulatory requirements and agreed strategy and timelines.
  • Responsible for the local management of product registration documents in regulatory databases and repositories.

Your Background:
  • 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.
  • Ideally you will have an in-depth understanding of regulatory governance, medical and safety.

Apply:
For more information or to apply for this Regulatory Project Manager position, please contact Julie on 01438 870011 or email pharmacontracts@ckagroup.co.uk, quoting job ref 51241.

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.

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