Division Head of Regulatory Affairs

Responsibilities

• You deal with and respond to routine regulatory queries for information and documents in a timely, priority driven manner.
• You prepare, compile, review and/or submit regulatory documentation to regulatory authorities and Notified bodies.
• You write Module 3 documents - CMC
• You handle licensing and post licensing procedures on behalf of clients including clinical Trial Applications, National, Mutual Recognition and Centralised Applications, medical device CE marking and food supplement notifications.
• You complete International product registrations and export certifications as requested by clients and international regulatory agencies in the EU and in third countries.
• You perform dossier and development gap analysis (drugs, food supplements) and maintain current technical files and declarations of conformity in accordance with the Medical Device Directives.
• You respond to customer queries and questionnaires for regulatory information.
• You provide guidance to a team of 6-7 regulatory consultants

Key Requirements

• You have a master's degree (PhD preferred) in a relevant subject: biotechnology, chemistry, biology or a similar background.
• You have 8-10 years of experience in a similar position.
• You are computer proficient and can working with a variety of databases, word processing, spreadsheet, etc.
• Experience with vaccines and biotech products is a plus.
• You are able to create effective reports and analysis and you can communicate them in a timely and effective manner.
• You are able to work in a team environment with shifting priorities and requirements.
• You have people management experience.
• You have excellent communications and organisational skills.
• You are proficient in English and German. Other languages are a plus.
• You are willing to work at client sites in Europe.