Regulatory Manager

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

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In case of successful placement, we support you with:

- All administrative questions
- Finding an apartment
- Health - and social insurance
- Work permit and much more