Regulatory Affairs, UK Liaison
CK Group are recruiting for a Regulatory Affairs, UK Liaison to join a pharmaceutical company at their site based in Slough on a contract basis for 12-months.
Company: This company is a successful global biopharmaceutical company that discovers and develops innovative medicines and solutions for people living with severe diseases of the immune or central nervous systems. The company works across approximately 40 countries across Europe and the rest of the world.
Location: This Regulatory Affairs Liaison role will be based at our clients UK Head Office in Slough, Berkshire. It is 20 miles west of London and has easy access by car from both the M4 and M25. The offices are also accessible by public transport (bus and train). The company is currently working remotely until further notice is given.
Regulatory Affairs Role: The main purpose of the role will be to:
- Take responsibility for UK-specific regulatory oversight on marketed and investigational biologic and NCE products.
- Serve as the primary regulatory liaison with the MHRA; providing oversight of the transition of the MHRA through BREXIT to help ensure any impact on business continuity is minimised.
- Prepare and deliver regulatory operational plans for assigned projects/products within the broader EU region.
Further responsibilities will include:
- Evaluating relevant UK regulations and guidelines, and the BREXIT process critically for their impact on new drug development activities/marketed products.
- Supporting the Global Regulatory Leader and/or EU lead for the delivery of timely approvals and product information in keeping with the needs identified by the business and markets.
- Leading the planning, preparation and delivery of both simple and complex submissions throughout the product's life cycle from either a global and/or regional perspective.
Your Background: To succeed in this role, you will have:
- A background in Life Science with a strong Regulatory background - preference for a successful track record in biologic and pharmaceutical product submissions.
- In-depth knowledge of the drug development, CTA, product registration processes and the MHRA.
- Demonstrated experience preparing chemistry, pre-clinical and clinical CTA submissions.
Apply: For more information or to apply for this Regulatory Affairs Liaison position, please contact Hendre Moolman on 01438 842 970 or email firstname.lastname@example.org, quoting job ref 49367.
It is essential that applicants hold entitlement to work in the UK.