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 £45.64 per hour PAYE depending on experience.
Regulatory Affairs Specialist Role:
? Ensures that marketing authorizations are maintained in compliance with related regulatory areas, through performing the necessary activities, including variations and renewals, with a high standard and within the agreed timeframes and communicates approvals to stakeholders through the correct processes.
? Works with Regulatory Affairs Europe to develop and implement regulatory strategies (including scientific advice and paediatric investigational plans, or orphan designation), identifies regulatory risks, and enables earliest possible approval. Ensures regulatory strategies are aligned with local business objectives and deliverables.
? For assigned products, ensures timely preparation and maintenance of local Summary of Product Characteristics, Patient Information Leaflets, Prescribing Information, packaging material and other applicable regulatory documents according to Company and local standards and Artwork Management procedures. Implement Prescribing Information within the correct timeframes for compliance.
? Ensures availability of packaging material, including patient information leaflets and all other artwork in a timely and correct manner and according to relevant Artwork Management procedures.
? Ensures adequate support to other functions to enable compliance in areas related to regulatory, such as PSUR submissions and review of promotional material.
? 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 52218.
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: Julie Marshall
- Phone: 01438 723 500
- Reference: 52218
Website: CK Group
- Posted: 16th November 2021
- Expires: 14th December 2021