Swissmedic Consultant

November 3

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SSI Strategy

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Pharmacovigilance • Medical Affairs • Drug Safety • Drug Launch • Project Management

51 - 200

💰 Private Equity Round on 2021-09

Description

• Provide regulatory consultancy to clients and propose registration strategies for new product developments, line extensions and product maintenance plans, including advice on contents and timing of submissions as requested with a focus on submissions to Swissmedic. • Provide regulatory advice on development strategies required for drug development from early development stages through to marketing authorisation applications, variations and renewals. • Support clients in organisation, preparation and conduct of Scientific advice procedures and other relevant meetings with Swissmedic, including preparation and compilation of briefing documents. • Manage and supervise relevant contacts and meetings with Swissmedic. • Initiate and complete marketing authorisation applications to Swissmedic, including co-ordination and management of responses to competent authority questions and post-marketing commitments. • Co-ordinate and support preparation of regulatory documents (e.g., Swiss Module 1, including product information and mock-ups). • Initiate and complete licence maintenance applications (variations, line extensions, renewals, PSUR submissions) under the respective scheme. • Ensure that content and format of CTD documentation is in compliance with current requirements and guidelines. • Act as a Swissmedic specialist for international collaboration projects such as Project Orbis and Access Consortium. • Understand, advise and support clients with MAA and MAH responsibilities and requirements for Switzerland.

Requirements

• A university degree in a scientific discipline • Work experience in the regulatory affairs environment in Switzerland • Experience in regulatory writing (e.g., Scientific Advice Briefing Book, CTD Modules, ODD applications) is desirable • Proficiency in German and English; French and/or Italian is a plus • Strong communication skills and intercultural sensitivity