CMC Manager

Proclinical is seeking a Regulatory Affairs CMC expert for an innovative client, to be based in Switzerland on a contract basis. As Regulatory Affairs CMC expert you will take a lead in documenting CMC submissions and archiving documents in document management systems.

Role Overview:

• Responsible for organization and preparation CMC documents for filings from marketing authorisation to post-approval supplements, renewals and responses to questions across all regions.
• Co-ordinate the preparation of responses to CMC questions from regulatory authorities.
• Apply agreed strategy for minor/routine submissions and query any apparent deviations.
• Track progress against regulatory strategy time-lines for submissions and alert leadership to potential discrepancies.
• Participate in interdisciplinary change management and evaluate the regulatory relevance of proposed CMC-changes
• Actively assess potential for upcoming new or updated regulatory guidance to impact on assigned scheduled submissions.
• It is essential you have strong communication skills - oral and written organizational skills and an understanding of drug development process in particular CMC- specific regulatory knowledge & experience.
• Typically requires a BA or BS degree in a relevant discipline and relevant experience in CMC Regulatory Affairs.
• Strong technical and regulatory writing experience.
• Able to manage multiple projects with competing deadlines.

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 call Jay Foster on +44 203 752 0309 or upload your CV on our website - www.Proclinical.com.
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.

#LI-JF1