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.
£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
• 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
• 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
Our client is a global healthcare company, taking on some of the world's biggest healthcare challenges.
This Regulatory Project Manager role is based at our clients site in Brentford, Greater London.
For more information, or to apply for this Regulatory Project Manager position please contact the Key Accounts Team on 01438 870011 or email firstname.lastname@example.org. 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.