Description
Global Program Regulatory Manager wanted for our Basel based client in the pharmaceutical sector.Your experience/skills:
- Excellent knowledge of regulatory submission and approval processes as well as portfolio brand management
- Proficiency in terms of product licenses, especially regarding preparation of documents for EU license renewals
- Expertise in HA negotiations as well as a solid understanding of post-marketing / brand optimization strategies and commercial awareness
- Languages: fluent English both written and spoken
Your tasks:
- Maintaining product licenses world-wide for assigned products as well as preparing IND/NDA Annual Reports and DSURs
- Operationally executing specific regulatory deliverables relating to world-wide maintenance, upkeep and lifecycle management of assigned global portfolio brands
- Preparing all necessary supporting documentation for EU license renewals, EU variations and PSUR submissions
- Addressing HA requests and leading preparation of HA responses
- Managing interactions with RA colleagues in CPOs and participating in regulatory subteams; preparation of IND/NDA Annual Reports & DSURs
Start: ASAP
Duration: 6MM+
Location: Basel, Switzerland
Ref.Nr.: BH12934
Does this sound like an interesting and challenging opportunity to you? Then take the next step by sending us your CV as a Word document and a contact telephone number.
Due to work permit restrictions we can unfortunately only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.
Going the extra mile…
New to Switzerland? In case of successful placement, we support you with:
- All administrative questions
- Finding an apartment
- Health - and social insurance
Work permit and much more