Regulatory Affairs Specialist (f/m/d)

In this role you will gain (further) competence and experience in RA management, procedures, tools and AOP Health products.

• Prepare documentation and Module 1 compilation, including CPPs, GMP certificates, price certificates, statements and other types of declarations, notarised/legalised/apostilled copies of documents, etc.
• Ensure regulatory compliance by maintaining relevant data and documents in the Regulatory Database and Document Management System
• You will perform various administrative regulatory tasks (e.g. ordering and checking of documents for Module 1)
• Coordinate responses to questions from Authorities and timely submissions
• Communicate with regulatory authorities worldwide and internal stakeholders
• Keep up to date with national and international legislation and guidelines, e.g. Austrian Medicines Act, EMA and EC guidelines, etc.
• Coordinate consultants and external partners, e.g. MAHs, distributors, etc.

• University degree in Natural Science
• 1-2 years experience in the pharmaceutical industry is an advantage
• Ability to plan and prioritise
• Attention to details and ability to deliver high quality documentation
• Strong communication skills to liaise with internal and external partners with different cultural backgrounds
• Full proficiency in MS Office, knowledge of Sharepoint is a plus
• Fluent in English and German, any other language is a plus

• A position with personal responsibility and space for creativity
• Open corporate culture with the opportunity to bring in your own ideas
• Highly motivated, agile, and international team
• Great opportunities for personal and professional development
• Attractive work environment with excellent career opportunities and flat hierarchies
• Competitive salary package plus bonus and various benefits
• Gross monthly salary provided for this function is a minimum of EUR 3.300.- based on full-time employment. Any potential overpayment depends on professional experience and qualifications.