Job Details

Job Summary:

Take responsibility for a number of key projects. This high level strategic role will include taking the lead on product launches within the EU, providing input into the Global Regulatory plans for development strategies, submitting Clinical Trial Applications, project managing submission of Scientific Advice briefing packages & MAAs (or line extensions/Type II variations). Contact Theo Moore or Matt Greig on 0207 801 3380 or email CV@advregulatory.com

Requirements:

Title: Regulatory Affairs / Regulatory Affairs Senior Manager – Strategic Team Leading role for EU Launch & development activities / M4 Corridor

Location: Berkshire, M4 Corridor, Maidenhead, Slough, Reading, Uxbridge, Chiswick, Twickenham

Background: As a Senior Manager in the EU Regulatory team, this position plays a key role in providing support to the Associate Director, with respect to building, mentoring & leading the team.

This position will be responsible for leading strategic decisions on development projects, maintenance activities and product launches and so you will therefore need to build and maintain strong relationships with commercial, EU regulatory agencies.

The Role: The holder of this position will take responsibility for a number of key projects for which you will co-ordinate all EU regulatory activities across a small portfolio. Initially you will the product launch of recently successfully approved product. The role will then focus on the development portfolio with a number of products in Phases 2 and 3 where you will provide the EU perspective into Global development plans, submitting Clinical Trial Applications, project managing submission of Scientific Advice briefing packages & leading future MAAs and line extensions/Type II variations. For maintenance activities, this would include the compilation of regulatory strategies, co-ordinating any submissions via collaboration with local Regulatory contacts, liaising with Commercial and mentoring/supporting junior team members.

Salary & Package details:
Salary up to 65K being someone who fully meets all the criteria with a performance related bonus of 10-15% at target + company car or car allowance

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TO APPLY:
If you wish to apply for this role please send your CV with a covering note to cv@advregulatory.com quoting reference number noted above. Alternatively to have a confidential discussion about this or other potential roles or career options call Theo Moore or Matt Greig on 0207 801 3380

About ADV Regulatory
Advanced Regulatory has operating since 2004. We are a recruitment business dedicated to the pharmaceutical industry, specialising in Regulatory Affairs. We match professional candidates to the best permanent, contract and interim roles in the market

Visit us at www.advregulatory.com

Key words: Regulatory, Regulatory Affairs, Reg Affairs, Regulatory Affairs Director, Regulatory Affairs Associate Director, Regulatory Affairs Senior Manager, Regulatory Affairs Manager, Regulatory Affairs Executive, Regulatory Affairs Officer.