CK Group are recruiting for a Regulatory Affairs Specialist to join a biopharmaceutical company at their site based in London on a contract basis for 12 months.
Up to £44 per hour PAYE depending on experience.
Regulatory Affairs Specialist Role:
? Ensures that marketing authorizations are maintained in compliance with related regulatory areas
? Develop and implement regulatory strategies identifies regulatory risks, and enables earliest possible approval
? Ensures timely preparation and maintenance of local Summary of Product Characteristics, Patient Information Leaflets, Prescribing Information, packaging material
? Ensures the correct and proper utilisation of Artwork Management System to generate mock-up artwork and to implement revisions to artwork.
? Participates in implementation of updated regulatory documentation according to Agency requirements and in-house guidance.
? BSc. Degree or higher (or equivalent qualifications) in pharmacy or a life-science subject.
? Comprehension of the fast-evolving EU/UK regulatory procedures especially in light of BREXIT, and EU and UK Medicines Legislation. Exposure to regulatory submissions and working with a Regulatory Authority.
? Good knowledge of labelling requirements.
? Experience in managing regulatory projects
? Meticulous attention to detail and be flexible enough to successfully handle conflicting time pressures and a large volume of work.
Our client is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. They have an interdependent global manufacturing network that\'s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
This Regulatory Affairs Specialist role will be based at our clients European Business Development and Licensing hub in London.
For more information, please contact the Key Accounts Team on 01438 870011 or email email@example.com. Please quote reference 52570.
It is essential that applicants hold entitlement to work in the UK.
You must have the right to work in the UK. Learn more
- Agency: CK Group
- Contact: Natasha Young
- Phone: 01246 457722
- Reference: 52570
Website: CK Group
- Posted: 7th January 2022
- Expires: 4th February 2022