Have you worked in the regulatory affairs for a while and now looking for a more senior and exciting role? Have you enjoyed managing multiple products and dealt with drug device combination products or medical device submissions? Are you looking to relocate to Switzerland? Then the following position is just right for you!!
• You will be responsible for 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
• As a 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
• University Degree in natural sciences, pharmacy or medicine
• At least 4 years experience in regulatory affairs 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 especially sections 2.3.P and 3.2.P
• Good knowledge of the human anatomy and physiology, pharmacokinetics and toxicology. Specific knowledge of the vascular system and associated diseases would be an asset.
• Fluency in English and German. Any additional language is welcome
• Well-organized, team-oriented and flexible personality who is able to work under pressure, with tight timelines and in a multidisciplinary environment
• Excellent £££ can be discussed at application.
• Relocation package and assistance in finding accommodation
• The role is based in Zurich, Switzerland.
If this role is of interest to you, then kindly contact Abhijeet Roy on Protected content or call Protected content an initial discussion quoting ref Protected content