CMC Expert
This vacancy has now expired. Please see similar roles below...
Proclinical is seeking a Regulatory Affairs CMC expert 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.
Job Responsibilties:
- 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.
- Actively assess potential for upcoming new or updated regulatory guidance to impact on assigned scheduled submissions.
Skills and Requirements:
- 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.
Related jobs
Highly Competitive
Paris, France
Proclinical is seeking a dedicated and strategic individual for the role of Associate Director, Field Business Lead.
Highly Competitive Salary
Cambridge, USA
Proclinical is seeking a dedicated QC Microbiologist to support our vaccine manufacturing site. This is a contract position located in Cambridge, MA.
Highly Competitive Salary
München (81249), Deutschland
Proclinical sucht einen engagierten regionalen Vertriebsleiter für die Osthälfte Deutschlands im Bereich Urologie.
Highly Competitive
Deutschland
Proclinical are currently in search of a dynamic Statistical Project Leader.
Highly Competitive
Tuttlingen, Germany
Proclinical sucht einen Systems Engineer - Instruments für einen Kunden aus der Medizintechnik-Branche.
Highly Competitive
Singapore River, Singapore
Proclinical are recruiting for a Senior eCommerce Manager APAC (6 months maternity cover) to join a pharmaceutical organisation.
Highly Competitive
Tuttlingen (78532), Deutschland
Proclinical auf der Suche nach einem Systems Engineer (m/w/d).
Highly Competitive
Singapore
Proclinical is seeking a dedicated Automation Engineer to provide technical support for smooth manufacturing operations.
Highly Competitive Salary
Lexington, USA
Proclinical is seeking a dedicated Project Manager to lead IT projects within business applications and IT infrastructure. This is a contract position located in Lexington, MA.
Highly Competitive Salary
Indianapolis, USA
Proclinical is seeking a dedicated and innovative Electrical Engineer to join our Engineering Operations Team. This is a permanent position located in Indianapolis, IN.