Regulatory Affairs Specialist
3 weeks ago
Company Overview: SRG is a leading Biotechnology company based in Edinburgh, Scotland. We are seeking an experienced Regulatory Affairs Officer to join our team on a permanent basis.
Salary: £55,000 - £65,000 per annum depending on experience.
Job Description:
- We are looking for a skilled Regulatory Affairs Officer to build regulatory strategy, determine applicable regulatory requirements, and propose solutions to comply with regulatory requirements.
- The successful candidate will manage product license registration with the appropriate regulatory authorities worldwide, including US, EU, Canada, and other territories as required.
- This role involves preparing and compiling regulatory documentation, coordinating and executing regulatory submissions, and developing product labelling regulatory requirements.
- The ideal candidate will have previous regulatory experience within Medical Devices / IVD or pharmaceutical regulatory experience.
Required Skills and Qualifications:
- Scientific degree
- Experience of working within an FDA licensed manufacturing facility
- Negotiation skills to meet with and negotiate with regulators
Benefits:
- Private medical cover
- Life assurance
- Additional annual leave
- Cycle to work scheme
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