GPRM / RegCMC Senior Manager
A job vacancy for a GPRM / RegCMC Senior Manager has arisen at a leading global pharmaceutical company specialising in development of biological therapies. This company is one of the top 10 global pharmaceutical companies that operates in 140 countries worldwide and has market leading products in multiple therapy areas.
- The GPRM provides strategic and operational regulatory support for individual development programs in early development under the supervision of a Global program regulatory director and / or Global Therapeutic Area Leader.
- The GPRM ensures the execution of regulatory plans in line with agreed regulatory strategy.
- The GPRM may act as RA representative to one or more program teams and may have responsibility for liaising with country RA representatives and CTA Hub.
- Coordinates, plans, and prepares for submission of CTAs/INDs in assigned countries worldwide.
- Responsible for submission of Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs).
- Leads preparation of HA responses as required with RA program team representative and/or GTAL.
- Interfaces with CTA Hub representatives and RA Country organization as necessary.
- Responsible for finalization and on time submission of annual reports and DSURs across assigned regions
- For the right candidate this may also be expanded to act as RA representative on Early Development Program Teams, leading the creation of regulatory strategy and leading HA interactions.
Skills and Requirements:
- This requires a candidate with experience of these types of activities although candidates with only a couple of years of regulatory experience should be able to support these types of activities.
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 Sam Walker on +44 203 8569 336 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.