Regulatory Affairs CMC Manager

Highly Competitive
  1. Permanent
  2. CMC
Posting date: 01 Mar 2019

ProClinical is advertising a vacancy for a Regulatory Affairs CMC Manager with a pharmaceutical company. The applicant will support this company's Switzerland based team by working with them on their biologic product.

Job Responsibilities:

  • Planning, authoring, and reviewing CMC related submission documentation and providing input to, and being accountable for, the preparation of CMC dossiers for submission to Health Authorities (BLA / MAA / IND / CTA etc.).
  • Planning, preparing, and reviewing CMC components of briefing packages in connection with health authority scientific advice and (pre-)submission meetings.
  • Identifying potential CMC regulatory risks to the strategic / operational plans and proposing options to mitigate risks.
  • Providing CMC Regulatory support to pre-approval and GMP inspections.
  • Ensuring compliance with Health Authority CMC related Regulations and ensuring awareness of cell and gene therapy guidelines.
  • Liaising with cross-functional CMC and manufacturing team members and external providers to ensure timely and effective regulatory submissions in support of product progression.
  • Acting as point of contact for agency interaction
  • Undertaking project management/lead responsibilities

Skills and Requirements:

  • Minimum of 5 years of experience in Regulatory affairs with expertise in CMC.
  • Experience in CMC biologic drug development
  • Strong working knowledge of the EU and FDA CMC regulations
  • Proven track record in leading in-direct teams with cross functional scope.
  • Strong communication skills to internal and external audiences.
  • 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 in 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 Jay Foster at +44 203 752 0309 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.