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.
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.
- 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.
For more information or to apply for this Regulatory Project Manager position, please contact Julie on 01438 870011 or email email@example.com, 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.