3 days ago

Regulatory Documentation Specialist

AXEPTA SA

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Regulatory Documentation Specialist

My client is an innovating, dynamic and growing international pharmaceutical company currently expanding their regulatory team in Switzerland, Vaud Canton. Due to this growth my client is looking for a Regulatory Document Specialist to join them on a permanent contract. Responsibilities : · Assist and c oordinate product dossiers prepar ation, maintenance and renewals. · Principal contact with dossier management system team or service provider, as needed. Responsible for administrative document management and samples to support registrations and renewals. · Establish/follow processes to ensure timely preparation of planned regulatory filings. · Support for the preparation of files · Coordinate the const itution and/or tracking of Marketing authorization dossiers, variations and renewals globally. · Assure timely receipt of administrative documents and their legalisation necessary for registration, renewal and variation files · Coordinate supply of samples required t o support registrations. · Write SOPs, forms, etc. to describe the day - to - day operations of function. · Propose/implement process improvements Your profile: · BSc in Scientific, IT or Administrative discipline or equivalent experience. · 5 years in a regulatory affairs department. · 2 years experience in a similar position · Experience of coordination with service providers. · Planning, organising and time management skills; · Problem solving and analytical skills; · Ability to identify opportunities/major issues and to communicate impact · Demonstrated ability to deal with rapid change · Effective verbal and written communication ski lls · Fluent in English

Quai du Seujet 12 1201 Genève