Senior Regulatory Affairs Manager, EMEA in London
Hendre Moolman at CK Group is recruiting for a Senior Regulatory Affairs Manager to join a pharmaceutical company at their site based in Stockley Park on a contract basis for an initial 6 months.
The Company: A global biopharmaceutical company who are committed to helping patients who are living with a wide range of debilitating and chronic diseases, from cancer to psoriasis.
The Location: The role is based at our client's site in Uxbridge which is easily commutable from central London and the Home Counties region, with great commuter and international travel links.
The Role: The main purpose of the role will be to:
- Contribute to the development of EU regulatory product strategy based on strategic imperatives, product knowledge, global and regional regulatory requirements.
- Maintain awareness of emerging issues that may impact regulatory product strategy and EU regional business.
- Work with Regulatory Franchise Team Leadership to ensure that product development programs and life-cycle plans are aligned with strategic oversight.
Further responsibilities will include:
- Working with other functions, developing and contributing to the preparation and content of high quality regulatory dossiers such as, scientific advice requests, orphan medicinal product designation applications, paediatric waiver requests, MAAs and variations.
- Responsibility for interactions with the European Medicinal Agency (EMA), and National Regulatory Health Authorities within the EU for product related discussions.
- Reviewing draft protocols, acting as Regulatory Franchise Team representative in clinical study teams and liaises with the individuals with CTA or CRO oversight responsibility.
Your Background: To succeed in this role, you will come from a Life Science background with experience in European Regulatory Affairs.
- Experience in Haematology/Oncology or Inflammation/Immunology drug development is preferred.
- Recent experience of EU Centralised Procedure required.
The Benefits: The role offers a West London location, with an initial 6 month contract, and a competitive rate working on a strong pipeline.
For more information or to apply for this position, please contact Hendre on 01438 842 970 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 45541 in all correspondence.