Description
Regulatory Manager wanted for our Basel based client in the pharmaceutical sector.Your experience/skills:
- Science based BS or MS with requisite experience and demonstrated capability
- 4+ years' working experience in regulatory and drug development in a global environment in the pharmaceutical industry
- Strong knowledge of regulatory submission and approval processes in EU/EEA region and Health Authority negotiations
- Languages: fluent English both written and spoken
Your tasks:
- Implementing regulatory strategy and managing operational activities by providing input into global regulatory strategy including identification of gaps or risks for assigned regions
- Planning and facilitating presentations to internal boards on regulatory strategy
- Developing and implementing regulatory readiness and preparing paediatric investigation plan
- Determining requirements for Health Authority, facilitating preparation and finalisation of briefing books and summary documents, leading rehearsals for HA meetings and serving as local HA liaison for EMA
- Compiling, reviewing and submitting clinical trial applications and global dossier summary documents
Start: ASAP
Duration: 12MM+
Location: Basel, Switzerland
Ref.Nr.: BH12431
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