Snr Manager Global Regulatory Affairs CMC – South East, UK

Reference: Oli07102021AB

Expiry Date: 06-11-2021

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Windsor and Maidenhead
United Kingdom

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Job Description

We are recruiting for a Regulatory Affairs CMC professional to lead and support post-approval projects for a global pharmaceutical company in the South East of England (M4 Corridor). This is a permanent role.

Who is our client?

Our client is a major biotechnology company with an impressive level of growth and achievement. This organization is now expanding their Regulatory Affairs CMC team across the world. They are a global, highly profitable, R&D driven business that has over the years pushed the boundaries of what is possible in order to transform patients’ lives. This company invests heavily in cutting-edge scientific research, it supports and develops its people and produces successful drugs that make real difference to people around the world.

We are seeking an individual who wants to gain more M3 build experience, learn and consolidate how to develop strategy in time for submissions in the EU, US and other major markets.

What is there for you?

  • Become part of a highly successful company that nurtures a team culture of mutual respect and support.
  • Work on variety of small molecule projects – variations, new formulations, renewals, market expansion projects in the EU, US, Canada and the rest of the world.
  • moving on to oligonucleotides and gaining biologicals experience in time may be possible for the right candidate. This will be a highly visible role as you will be one of the small molecule experts in the company.
  • The location is easily commutable by train from London and Reading and is easily accessible via car with company car parking on premises.
  • Flexible working hours are available post Covid-19 and the role comes with very competitive salary, bonus and a stock plan.

What do you need to bring to the table?

  • It is essential to have at least 4-5 years of Regulatory Affairs CMC experience supporting and authoring/re-authoring expert reports into dossiers for small molecules (authoring and compiling of IMPDs as well as Module 3 for initial MAA/NDAs).
  • Regulatory CMC strategy experience is needed as well as experience of direct communication and negotiation with Health Authorities.
  • Demonstrated leadership, ability to work independently (this company will empower you) and communication skills are needed.

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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