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Division Head of Regulatory Affairs
Join a leading group operating in the Pharmaceutical,Medical Device and Food Suplement industry
- 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
- 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.