Regulatory Affairs CMC Manager

Highly Competitive
  1. Permanent
  2. Project Manager, CMC
Posting date: 29 Mar 2019

ProClinical is advertising a vacancy for a Regulatory Affairs CMC Manager with a leading biotechnology company. The organisation prides itself on its historic ambition to treat and assist patients with a range of serious and chronic medical conditions. With a broad range of therapies, including treatments for haemophilia and primary immune deficiencies, this exciting company is offering the perfect opportunity to join their Swiss-based team.

Job Responsibilities:

  • Developing and executing global regulatory strategies.
  • Working with Quality and Manufacturing Departments and with regional regulatory experts.
  • Authoring the CMC dossier CTDs.
  • Compiling CMC documentation.
  • Reviewing the CMC section of the Investigator's Brochures.

Skills and Requirements:

  • A BS/BA/Masters/Ph.D. in Natural Science.
  • Experience in the pharmaceutical industry and/or biotech industry.
  • Fluency in English, with German a plus.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Hugh Pickerill at +44 203 854 1079 or upload your CV on our website -

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.