One of the Global Leaders in the Life Sciences space, HQ'd in Switzerland, are now expanding their Regulatory Team as they undergo a huge transformation. They are searching for a Senior Regulatory Affairs professional with experience in market expansion to help drive their business growth. The company has chosen a new route to benefit the health of over a billion people globally and you could be a part of this revolutionary change, working closely with multiple markets.
The role:
- Be accountable for logistics, preparation (including content), quality check, and delivery of regulatory submissions in new markets
- Ensure that regulatory submissions are complete/prepared following the current standards in a timely manner, as well as that responses to requests from regulatory authorities are complete and timely prepared following the current standards.
- Ensure the maintenance of regulatory databases and departmental filing systems to facilitate accurate and retrievable records of regulatory activities
- Closely collaborate with affiliates and regional functions in handling requests and challenges related to regulatory aspects.
- Be responsible for change management activities related to commercialised products and to establish clear process and SOPs for post-market regulatory activities.
Requirements:
- Ph.D, MSc or BSc academic certification within a relevant life science field
- 5+ years' experience in Regulatory Affairs, with technical experience in international markets and regulations (FDA, EMA, EMEA, ICH etc.)
- Experience in collaborating with affiliates and regional functions and dealing with handling requests for change management activities for commercialised products.
- Fluent spoken and written English
In return, my client offers a competitive salary package, unrivalled progression opportunities and an attractive hybrid remote working model.
Please apply by sending me your updated CV or through the link.
