Senior Manager Regulatory Affairs CMC, lead and support EU submissions for NCEs, London

Reference: Oli10486

Expiry Date: 02-01-2020

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
London
Greater London
United Kingdom

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Job Description

We are hiring for a Senior Manager Regulatory Affairs CMC for an international Biopharmaceutical company.

Location: London, M4 Corridor.

Our client is an R&D driven Biopharmaceutical company with an impressive pipeline of product as well as a number of blockbusters. This is a top biopharmaceutical company that is now expanding their Regulatory CMC teams both in the UK and in the US. This role is based in London and will support small molecules coming up in development for EU submissions.

Our client has been highly successful over the past decade and their growth is set to continue for the next 10 years. They have put themselves in this position by investing heavily in cutting-edge scientific research and producing successful drugs that are making a real deference to patients across the world. This company invests in its people, and in this role you will be supported by an experienced Regulatory Affairs CMC Director.

Responsibilities

  • In this role you will provide Regulatory CMC expertise and will be responsible for assigned projects, supporting and leading submissions in the EU for products in development.
  • Responsibilities will include writing IMPDs for specific molecules, new MAAs as well as having an input in the overall Regulatory CMC strategy.
  • You will be the primary contact for the Health Authorities for assigned region/s – mainly the EU, Middle East and North Africa or Asia – Pacific.

What we need

  • We need an experienced regulatory affairs professional with over 5 years’ relevant experience in Regulatory Affairs CMC.
  • You would have experience in successful authoring and contribution to timely delivery of submission documents - CMC sections of IMPDs, MAAs etc. Experience working on late stage development projects.
  • Direct communication and negotiation with Regulatory Agencies on CMC matters as well as experience managing all AH interactions for assigned region/s.

Benefits

  • This role will give you the opportunity to become an integral part of a growing Regulatory Affairs CMC team serving as a Product Lead.
  • You will receive real support from talented and highly experienced Regulatory CMC Director helping you on the career path to become an AD in the future.
  • The salary package is very competitive and includes a bonus (~10%), company benefits as well as extensive company benefits.
  • The location is easily commutable by public transport from London, Berkshire and Reading. There is car parking for those who drive. 

 

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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