Regulatory Affairs Manager
Full job description
Hunter Selection
Salary: £72,000 per year
Regulatory Affairs Manager
North Wales
21057/617
Monday – Friday.
£55,000 – £60,000 DOE
My client has vast international expertise in the manufacture of pharmaceuticals and biopharmaceutical formulations as well as Active Pharmaceutical Ingredients (API).
A fantastic opportunity has arisen to join this global & reputable manufacturer. This company manufacture high quality products from their state-of-the-art production facility in North Wales. The company are introducing innovative business models to create new business opportunities and continue to grow year on year. The company has successfully created an integrated multi-technology capability to manufacture all types of dosage forms including sterile injectables and lyophilised products
They are looking to bring on an experienced Regulatory Affairs Manager with Pharmaceutical experience to head up and grow a strong team.
Role & Responsibilities:
- To manage the maintenance of regulatory licences as required (all post approval activities)
- GMP review of documents of all approved products
- Management of life cycle management team
- To have responsibility for over the counter products
- To deputise as required for the Head of Regulatory Affairs to ensure that the department can respond quickly and effectively to the demands of the company regarding post approval matters
Knowledge, Skills & Experience:
- Membership of the Organisation for Professionals in Regulatory Affairs (TOPRA) is preferable
- Experience in a supervisory capacity
- Substantial experience in regulatory affairs, including hands-on experience with UK national (essential) or MRP/DCP applications (desirable)
Benefits Package:
- Monday – Friday
- Up to £60,000
- Rewards platform,
- Salary sacrifice schemes
- Subsidised canteen
- Free parking
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