Regulatory Affairs Senior Manager CMC – Lead Submissions for NCEs, UK, M4 Corridor

Reference: OLI010493

Expiry Date: 17-12-2020

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Windsor and Maidenhead
United Kingdom

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Job Description

We are seeking a Regulatory Affairs Snr Manager CMC to lead projects in development for small molecules in the South East of England.

This is a permanent role leading submissions for NCEs in the EU and the rest of the world for an international pharmaceutical company.

Our client is a fast-moving, global pharmaceutical company which is an 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 is people and produces successful drugs that make real difference to people around the world.

Main responsibilities:

  • Lead as assigned small molecule projects in development providing regional strategic and operational Regulatory CMC expertise.
  • Write and review global and regional Regulatory CMC submission documents, IMPDs, INDs, new MAAs and NDAs etc.
  • Manage CMC aspects of Health Authority questions.

What is there for you?

  • Become part of a highly successful pharmaceutical company that nurtures a team culture of mutual respect and support.
  • Work on variety of projects in development, supporting drugs in Ph2 and Ph3.
  • The locationis easily commutable by train from London and Reading and is easily accessible by car with company car parking on premises.
  • Flexible working hoursare available and the role comes with a competitive salary and company bonus.

Experience needed:

  • It is essential to have at least 5 years of Regulatory Affairs CMC experience.
  • Experience in successful authoring and compiling of IMPDsfor originator products as well as MAA, Module 3
  • Experience of direct communication with the Health Authorities.
  • Demonstrated leadership, communication skills and emotional intelligence.

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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