Description
Global Regulatory Manager wanted for our Basel based client in the pharmaceutical sector.Your experience/skills:
- BSc or MSc with requisite experience and demonstrated capability, preferably degree as MD, PhD or PharmD
- 2-4 years professionalism in regulatory and drug/biologic development spanning activities in Phases I-IV
- Experience with regulatory submission and approval processes in one or more major regions in addition with familiarity within a global or matrix environment and cross-functional teams in the pharmaceutical industry
- Ability to understand of post-marketing and brand optimization strategies and commercial awareness preferred
- Confidence in HA negotiations
- Languages: fluent English both written and spoken
Your tasks:
- Implementing a global regulatory strategy for timely submissions and approval with the best possible label based on available data as well as integrating the global strategy into regional submissions worldwide
- Specifying requirements and setting objectives for Health Authority (HA) interactions with GPRD
- Collaborating with HAs as appropriate in meetings with GPRD as well as coordinating and planning rehearsals for HA meetings
- Submitting Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs)
- Identifying issues, gaps, and tradeoffs affecting optimal and timely submission and approval
- Organizing and preparing submission of dossiers in assigned regions worldwide along with reviewing of global dossier summary documents
Start:
Duration: 12MM+
Location: Basel, Switzerland
Ref.Nr.: BH12426
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