Regulatory Affairs Senior Associate Health
Jim Gleeson is recruiting for a Regulatory Affairs Senior Associate to join a leading global consumer products company.
The role will be based in their Home Counties office but with very significant home-working allowed, especially for those withlong commutes.
Responsibilities: As Regulatory Affairs Senior Associate you provide regulatory support for the launch of new OTC products in the UK.
Key duties will include:
- Regulatory new products development and compliance for UK Marketing Authorisations in the portfolio, including preparation and submission of variation packages and renewals to the Regulatory Agency
- Oversight of CMC aspects for UK type I and II variations such as site transfers, change of manufacturing processes, FSP and analytical methods
- Gap analysis of quality dossiers for licensing, including review and quality check of CMC documents for electronic submission to MHRA
- Participation to due diligence activities related to new products
- Interpretand apply all relevant legislation in the UK to keep the business up to date on national regulatory trends, risks and opportunities
Qualifications: As Regulatory Affairs Senior Associate you will require:
- A medical degree
- Industry based experience in a regulatory affairs function supporting Consumer Health or OTC products
- A thorough understanding of the current UK and European regulations, laws, guidelines and industry requirements
- Familiarity with UK product launch regulationsBenefits: Salary of around £55.000 plus bonus, car allowance and other generous benefits..
Apply: It is essential that applicants hold entitlement to work in the UK. Please quote job reference 53727 in all correspondence.