Senior Manager - Regulatory CMC

Germany / Germany, Mannheim, Baden-Württemberg
Jan 02, 2018
Feb 01, 2018
Laura Hutchings
Contract Type
Full Time

Senior Manager Regulatory CMC

My client is a leading provider for the pharmaceutical and medical device industry. Expert teams provide innovative solutions to their clients globally.

For you, this means a range of job and career development opportunities and lots of potential to continue learning and to further develop your skills.

The responsibilities of the Senior Manager - Regulatory CMC

  • Compile and check pharmaceutical quality documentation (Module 3, QOS, IMPD, ASMF etc.) for national and international markets
  • Prepare Gap Analyses of pharmaceutical quality dossiers in the context of marketing authorization projects, Due Diligence
  • Set up responses to deficiency letters from authorities
  • Supervise development projects and marketing authorization procedures with regard to the pharmaceutical quality documentation
  • Compile and review Product Quality Reviews (PQRs)
  • Coordinate and perform CEP procedures and perform Life Cycle Management processes with regard to the pharmaceutical quality documentation (change control procedures, prepare and submit variations, site transfers etc. with regard to strategy and content)

On offer to the Senior Manager - Regulatory CMC

  • Diversified and challenging job
  • Cooperating partnership and leeway
  • Flexible working hours based on trust
  • Continuous development opportunities through knowledge and experience as well as training

The profile required

  • Degree in natural sciences (preferably pharmacy, chemistry or biology)
  • Experience in Pharmaceutical Quality with a focus on regulatory aspects of the pharmaceutical quality documentation
  • Practical experience in regulatory submissions (MAA, CTA, CEP, Life Cycle Management processes etc.) and in Regulatory Compliance
  • Experience in biologicals and biosimilars
  • Excellent communication skills, team spirit and social competence
  • High sense of responsibility and self-motivation
  • Fluent in English, spoken and written

To apply please email me at or call +44207 002 0346

Hydrogen UK Limited is acting as an Employment Agency in relation to this vacancy.