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Job Details

Senior Regulatory Manager. New Products - UK/Europe

Company: Morgan Prestwich Pharmaceutical Recruitment
Location: Hertfordshire
Reference: 0006971410
Closing Date: 16 Nov 17
Type: Permanent
Salary (£): 60,000 - 80,000
Benefits: Competitive Salary, Car Allowance, Bonus Scheme, Pension, Healthcare

Job Summary:

Senior Regulatory Manager. New Products - UK/Europe UK. Office based. South Central Area Assisting a fast developing and exciting growth company, with recent approved products close to launch.


Senior Regulatory Manager. New Products - UK/Europe

UK. Office based. South Central Area

Assisting a fast developing and exciting growth company, with recent approved products close to launch.

As part of continued upscale, our client seeks to employ a Senior Regulatory Manager - Focussing on New Products.

The Role

We are currently working with a fast growing client, who are continuing upscale within the business with pending launches of new Rare Disease products. They now seek to develop the Regulatory Affairs team for the European and potential global operations.

To support the Regulatory Director, our client seeks an experienced industry Regulatory professional to work as their newly created - Senior Regulatory Manager of Regulatory Affairs. The core focus of this new position will be concentrating on all new products.

The Senior Regulatory Manager / Associate Director will work alongside the Regulatory Head in developing the regulatory needs for both pending and recently launched products within the company portfolio. 

This will be a full time office based position, working in the South Central area of the UK.


The Senior Regulatory Manager will be managing all regulatory activities for the companies new products and ongoing new marketed product launches across all assigned European countries including; France, Spain, Italy, Germany and the UK, plus contributing to the future global reach including the US / Nordics / Benelux.

Responsibilities & Experience Required includes:

  • Managing the schedule of regulatory submissions; Experience including MAA's / CTA’s submissions for innovative regulatory pathways required
  • Post Approval experience - managing all new marketed products
  • Pre-Approval experience – At least 1 year within industry
  • Preparation and submission of dossiers across EU and ROW.
  • Experience in centralised procedures
  • Experience with the PDCO or involvement in writing Paediatric Investigational plans - Preferred
  • 6+ Years industry regulatory experience to date including; Strong Submissions and CMC related experience
  • Working knowledge of the regulatory management of medical devices for manufacturers and/or distributors - Also beneficial
  • Solid European and potentially global regulatory exposure
  • Regulatory Manager level experience – 2+ Years in Industry


On Offer:

A competitive salary, together with 20% bonus, Car Allowance, good contribution pension, plus an attractive annual long term incentive bonus scheme amongst others


Contact today for more information and include your most recent CV and any support documentation.

S.Felton - +44(0)208 144 6778


Apply for this job: Senior Regulatory Manager. New Products - UK/Europe

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