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.
For GPRM1 (supporting RA Early Development) we need the following expertise:
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.
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.
Work Place / site Flexible – travel to Basel to meet team expected. Location on site for occasional days preferred.