Regulatory Affairs Manager – Zurich area
Providing Flexible Resourcing Solutions
CTC Clinical Trial Consulting, founded in Basel, Switzerland in 1997, is a specialist staffing organisation, providing flexible resourcing
solutions to the pharmaceutical industry in Switzerland, with contract and permanent placements in clinical development, data management,
statistics, regulatory affairs and medical marketing.
For one of our clients, we are currently looking for a
Main Responsibilities:
- Advising and supporting project teams and management on regulatory issues especially in relation to drug related aspects. Reviewing and editing documentation in the common technical document (CTD) format
- Participating as a team member in new (combination) product projects and variation projects with responsibility for regulatory and labelling aspects. Supporting other RA managers in worldwide combination product submissions.
- Establishing and maintaining relationship with the regulatory authorities, affiliates and distributors
- Keeping abreast on the latest developments in worldwide regulatory legislation and requirements, especially those pertaining to combination products
- Writing, reviewing and approving medical device labelling and promotion material, contributing to risk analyses, testing plans and reviewing specific test results
Qualifications and Experience:
- University Degree in natural sciences, pharmacy or medicine
- Several years experience as a Regulatory Affairs Manager in a medical device company with responsibility for drug/device combination products including a proven track of successful submissions and approvals. Specific regulatory experience with implantable drug-device combination products would be an asset
- Thorough knowledge of regulatory procedures and requirements for combination product in important markets (CE, USA, Japan, Canada)
- Thorough knowledge of applicable regulations and guidelines relating to combination products in above mentioned countries, including applicable ICH guidelines
- Experienced in writing, reviewing and submitting regulatory documentation in the CTD format
- Good knowledge of the human anatomy and physiology, pharmacokinetics and toxicology
- Specific knowledge of the vascular system and associated diseases would be an asset
- Proficiency in Microsoft Office applications and literature citation programs
- Well-organized, team-oriented and flexible personality who is able to work under pressure, with tight timelines and in a multidisciplinary environment
- Fluent in both written and spoken German and English. Any additional language is an asset
- Relevant working/residency permit or Swiss/EU-Citizenship required
Our offer:
- Competitive salary and package
- The possibility for development and advancement within a growing and dynamic company
April 30, 2010
• Tags: Regulatory Affairs Manager, Switzerland Job in Zurich Area 8064, Zurich area, Zürich Switzerland • Posted in: General