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Job Details

Senior Manager- CMC- South East

Company: Meet
Location:
Reference: GSCMC
Closing Date: 05 Feb 17
Type: Permanent
Salary (£): 60,000 - 80,000
Benefits:

Job Summary:

Manage Regulatory CMC activities internationally providing strategy, CMC updates, advice to various teams including Regulatory strategy team leads.

Requirements:

Suitable for: CMC, Regulatory Affairs Manager CMC, Regulatory Affairs, Regulatory Affairs Manager, Senior Manager Reg Affairs, CMC Registration, Regulatory affairs strategy

Company Background

My client, an international pharmaceutical company is looking for a Senior Regulatory Manager with a strong background in CMC to join them on a permanent basis. 

Job Summary

Manage Regulatory CMC activities internationally providing strategy, CMC updates, advice to various teams including Regulatory strategy team leads.

Job Description

Duties you will be responsible for are (but not limited to) include:

  • Preparation of CMC documentation to support CTAs, MAAs and life cycle maintenance
  • Providing strategic scientific advice to support on going or pipelined projects
  • Develop and maintain relationships across a broad network of personnel including external companies, partnered CROs, Agencies and authorities and internal teams
  • Manage all aspects of module 2.3 documentation
  • Line management
  • Hands on experience with CP/DCP/MRP and National procedures
  • Exposure to International markets including MEA/LATAM and APAC

Key Skills

  • Specialist CMC background
  • Prior exposure to Biologics, Consumer Health  and or Biosimilars is advantageous
  • Life Sciences degree or above
  • Line management experience is ideal  

Location: South East

Salary: available on request

Full job description and company details are available upon application, apply below. This position is being dealt with by Georgina Stocker at Meet  on +44 (0)203 178 7488 or email Georgina.stocker@peoplewithchemistry.com if you would like to know more about this opportunities this will be 100% confidential

Meet are good people who are great at recruitment. We’re proud to partner with the industry’s leading Pharmaceutical, Biotechnology, Medical Device, Marketing Communications and Contract Research Organisations (CROs) worldwide, helping them to find and secure the best global talent available.  We pride ourselves on our open, friendly approach and are here to guide you through the recruitment process every step of the way.

Find out more about us at www.peoplewithchemistry


 

 

Apply for this job: Senior Manager- CMC- South East

Contact Information:

Address:  meet
Euston Tower Levels 32-34 286 Euston Road London
NW1 3DP
England
Tel:  +44 203 178 7488
Website:  Visit Our Web Site

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