For our offices in Vienna, Austria, we are looking for a
Senior consultant regulatory affairs (m/f)
- Dealing with and responding to routine regulatory queries for information and documents in a timely, priority driven manner.
- Prepare, compile, review and/or submit regulatory documentation to regulatory authorities and Notified bodies.
- Handle licensing and post licensing procedures on behalf of clients including clinical Trial Applications, National, Mutual Recognition and Centralized Applications, medical device CE marking and food supplement notifications.
- Complete International product registrations and export certifications as requested by clients and international regulatory agencies in the EU and in third countries.
- Dossier and development gap analysis (drugs, food supplements) maintain current technical files and declarations of conformity in accordance with the Medical Device Directives.
- Respond to customer queries and questionnaires for regulatory information.
Experience, skills and education:
- Experience with registering Biotech products and Biosimilars.
- Experience in dealing with European Medicines Agency (EMA) and centralized
- Master’s degree (PhD preferred) in a relevant subject:
- biology or a similar background.
- 5-10 years’ experience in a similar position.
- Computer proficiency and adaptability working with a variety of databases, word processing, spreadsheet, etc.
- Ability to create effective reports and analysis and communicate them in a timely and effective manner.
- Ability to work in a team environment with shifting priorities and requirements.
- Project management skills
- Experience with drug, medical device and food registrations.
- Proficient in English and German.
- Willingness to work at client sites in Europe.
Your salary will be based on experience but will meet the legal requirements according to the Austrian laws and regulations.
Apply for this position:
Send your application (e-mail or postal) to:
Michor Consulting and Trade Services GmbH
Please include the following information:
Personal data: Your home address, phone number and e-mail address
Resume: Preferably in PDF or WORD format
Letter of motivation
References and certificates