Regulatory / Director Regulatory Affairs CMC, NCEs, based in London

Reference: Oli10476

Expiry Date: 27-12-2019

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
London
Greater London
United Kingdom

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Job Description

Regulatory / Director Regulatory Affairs CMC, NCEs, based in London

We are recruiting for a Director, Regulatory Affairs CMC to lead projects in development for one of our clients based in Central London. 

This is a great role, permanent opportunity where you will have full autonomy, scope and leadership for your projects as a Director, Regulatory Affairs CMC.

Location: Central London

The pipeline is strong. Our client is part of a global pharmaceutical company with over 20 products in their pipeline. Based in London though, the EU leads its own development and submission plans. They have 3 approved products here, 5 in the pipeline and they operate with a flatter structure allowing easier, quicker decision making. The Regulatory Affairs team consists of around 15, all working on the same floor.

You will have strategic input for EU submissions and take the leadership for products in Ph 1 and Ph 3. However, this will be a hand-on role, and you will have to be ready to roll your sleeves and write first IMPDs, new MAAs, PIP and Scientific advice etc. We need a good communicator, calm, cool and collective, logical, evidence based and flexible on case-by-case situation. Soft skills are important in this role as there is no rush culture here and although this is not a traditional managerial role, being able to give help, support and guidance to team members and technical teams would be seen as an advantage.

The package is very competitive and it comes with company car, bonus, stock options, 25-day annual leave (plus additional days off between Christmas and New Year), the week has 35 working hours and you can work 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 Oli Dimitrov on +44 (0)207 801 3388 or 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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