requirements, mechanisms to optimise product development and to maintain compliance. Co-ordinate and provide guidance to company... relevant product area, development stage and experience of working directly with the EMA and Centralised Procedure. Experience...
CK Groupregulatory mechanisms to optimise product development (e.g. expediting FIH studies, Orphan Drug, conditional/accelerated... approvals, compassionate use and paediatric plan). Direct the development of the regional product label by collaborating...
CK Groupand you will be at the forefront of innovative drug development. Amgen’s product pipeline covers many Therapeutic areas, including: Oncology... and collaborative environment. The Global Trial Manager (GTM) role sits in the Clinical Program Operations (CPO) function, alongside...
Amgenplanning in accordance with national legislation and regulatory requirements and manage the development of the regional product...CK Group are recruiting for a Regulatory Affairs Manager to join a biopharmaceutical company who are based in Uxbridge...
CK Groupstatus, nature of changes, minor/significant product information changes within the assigned procedures (planned/ongoing... European Regulatory Liaison (ERL) in the development process of European regulatory and procedural strategy. Author regulatory...
Bristol-Myers Squibb