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Regulatory Affairs Manager EMEA & APAC Basel Switzerland,
Posted on : 10 February 2017
- People at our company appreciate the opportunity to shape our future and create impact.
- Encouraging leadership and inspiring ideas from our people has guided us through our proud history of pioneering innovations.
- In your role as a passionate and performance driven Regulatory Affairs Manager you will be responsible for the overall product registration strategies, coordination, implementation, execution, control and completion of product registrations world-wide except US.
- Preparing the Technical File for international registrations
- Registration of the new products world -wide except US
- Product lifecycle management and product license maintenance
- Set up registration strategies; execute registration process from dossier compiling to submission and approvals of assigned products throughout various regions
- University degree in a scientific discipline such as biology , pharmacy, chemistry, engineering or equivalent
- 5 years experience in General Regulatory Affairs, with at least 2 years of international regulatory experience
- Profound experience with international medical device (class II & III) regulatory approvals and submissions
- Proven track record of successful interactions with Health Authorities
- Excellent command of spoken and written English; any other language is an asset
- Effective communication and persuasion skills to interact across different levels and cultures
- Results-oriented in a dynamic environment
- Agility to handle and deliver on a multitude of projects, programs, and priorities paired with high sense for execution and teamwork
- Accountable personality with a structured and pragmatic working style
- Ability to build trust and drive engagements in others in a constantly changing environment
- Collaborative, emphatic and solution oriented individual
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