GRA - Regulatory Affairs Expert
CK Group are recruiting for a Regulatory Affairs Expert to join a global biopharmaceutical company at their site based in Slough on a contract basis for a period of 6 months, working remotely.
The main purpose of the role will be to;
- Contactperson for assigned responsibilities on the product, in alignment with Regulatory Lead
- Assume responsibilities for contact with 3rd party partners (mainly CROs), building strong relationships for assigned project(s).
- Responsible for providing regulatory expertise and strategy, in alignment with the Projects
- Support and deliver quality regulatory submissions in line with the applicable regulations, directives and guidelines, and in line with agreed strategies and timelines.
- To succeed in this role, you will come from a Life Science background with proven experience in a global regulatory affairs role in industry.
- Experience of EU regional regulatory procedures and legislation related to drug development and clinical trial applications; 5 to 10 years of global experience preferred in this field.
- Strong Project planning and management skills, being able to perform risk assessments, anticipating problems and providing creative solutions.
Entitlement to work in the UK is essential. For more information or to apply for this Regulatory Affairs Expert position, please contact Sam Cupit on 01246 457733 or email email@example.com. Please quote reference 52322.