SSI Strategy

Consultant – Regulatory Affairs/focus on Swissmedic

Are you an experienced specialist in Regulatory Affairs within Drug Development? Become a part of the SSI Strategy/NDA Group’s growing, highly qualified team!

As a Consultant at SSI/NDA you will provide our clients with strategic and operational support concerning regulatory affairs within drug development on a national level. You will manage and take part in complex and challenging projects from international and local companies within different therapeutic areas.

Key responsibilities

Regulatory Strategy, focus on Swissmedic:

· 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.

Marketing Authorisation Applications & License maintenance:

· 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

Looking for candidates who have:

· 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