Regulatory Affairs Specialist
CK Group are recruiting for a Regulatory Affairs Specialist to join a company in the Pharmaceutical industry at their site based in Maidenhead on a contract basis for 6 months.
Company: Our client is part of one of the largest Pharmaceutical companies in the world. Their consumer segment includes a broad range of products used in the baby care, skin care, oral care, wound care and women's health care fields.
Location: This Regulatory Affairs Specialist role will be based at our clientssite in Maidenhead, Berkshire.
Salary: Up to £56 per hour LTD or £41 per hour PAYE.
Regulatory Affairs Specialist Role:
- Support the Northern Europe Cluster team (as appropriate) for UK, Ireland & Malta across the Consumer Health portfoliorange.
- Development of regulatory strategies, preparation of regulatory applications and support maintenance activities within relevant therapy area.
- Define regulatory strategies (local and regional) in line with business plan.
- Complete identified regulatory activities to ensure all regulatory obligations and business objectives are met.
- Prepare and compile regulatory submissions (Marketing Authorisations Applications, Renewals Variations, Reclassifications etc.), responses to Regulatory Agency (RA) questions and other correspondence in accordance with EU & UK regulations and guidelines.
- Life Sciences or Chemistry graduate to honours level or equivalent.
- Must have UK market regulatory experience within pharmaceutical regulatory affairs and working with MHRA directly, ideally with some OTC experience.
- Brexit related regulatory knowledge and experience.
- Must have hands on experience in management of day to day UK and EU regulatory procedures.
- Ideally knowledge and experience of allied regulatory affairs areas such as Cosmetic, Medical Devices but not essential.
Apply: For more information or to apply for this Regulatory Affairs Specialist position, please contact Lucy Stendall on01246 457739 or email email@example.com, quoting job ref 49911.
It is essential that applicants hold entitlement to work in the UK.