Regulatory / Senior Manager Regulatory Affairs, Central London

Reference: Oli17112019

Expiry Date: 18-08-2020

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
London
Greater London
United Kingdom

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Job Description

We are seeking a Snr Manager Regulatory Affairs to work closely with an experienced Regulatory Project Lead in providing support to submissions in the EU and direction to the Regulatory strategy.

This role will be expected to give guidance to a range of projects in a range of regulatory requirements both for products in development and marketed products in the portfolio.  

This is a permanent role based in London.

Who is our client?

Our client is a global pharmaceutical company with a strong pipeline of over 20 product. Based in London, the EU leads its own development and submission plans and has 3 approved products and 5 in development. The regulatory affairs team consists of 15 professionals, all working under the same roof.

Key Responsibilities:

  • Support post-marketing licensing requirements and ensure effective liaison across the organization.
  • Manage the Clinical Trial submission process and ensure successful approval of CTA applications.
  • Define and optimize regulatory strategies for both post-approval and CTA submissions.
  • Lead responses to Health Authority questions.
  • Ensure through technical review of regulatory documents before submission. Regulatory Affairs CMC experience required.

Key Requirements:

Success in this role will require versatility and Regulatory Affairs experience across the whole lifecycle. You will need minimum 5 years of Regulatory Affairs experience in submitting CTAs, new MAAs as well as life-cycle management activities. Good knowledge of the European procedures is necessary. You need the Ability to liaise, negotiate and interact with Regulatory agencies.

In return the package is very competitive and it comes with a bonus, the week has 35 working hours and you can work 1-2 days per week from home. The location is central, easily commutable by public transport, it is close to the main train stations and also includes parking for those willing to drive to central London.

 

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact Theo Moore on +44 (0)207 801 3384 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.

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