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Form of work
SalaryWalker Cole International is searching for a Senior Regulatory Affairs Executive to join an established Pharmaceutical Business in the UK. As a Senior REgulatory Affairs Executive you will be in charge of the regulatory strategy for the registration and delivery of a range of new products from their identificaiton to launch, with a specific focus on the UK and EU markets.
Key roles and responsibilities
- Define country specific regulatory processes for marketed and developmental products
- Manage life cycle/post-authorization changes for UK relating to CMC, clinical, safety and product Information changes as well as knowledge of requirements of Minor and Major complex Variations
- Writing, Compiling and Publishing Dossiers for UK National & EU Submissions
- Evaluate the CMC components regulatory dossiers to ensure regulatory compliance is maintained during launch and maintenance phase
You must have:
- A degree within the life sciences/medicine
- International regulatory experience with new product introduction within the Pharmaceutical industry covering both National and European regulations
- Strong communication and project management skills
Regulatory Affairs | RA | Head of Regulatory Affairs| GMP | Pharmaceutical | Regulatory | Submission | Product Dossiers | EU | Global | MHRA | FDA | Good Manufacturing Practice | CTD | Common Technical Documentation | Module 1 | Module 2 | Module 3 | Module 4 | Module 5 | TMF | Trial Master File | Clinical | R&D | EMA | European Medicines Agency
