Regulatory Affairs Manager (f/m/d)

AOP Health is the European pioneer for integrated therapies for rare diseases and in critical care. To enhance our team in Vienna we are looking for a:

About the Role: In this role you are responsible for the development and implementation of regulatory strategies to ensure successful registrations and product launches for AOP Health products.

• You will be responsible for preparing and compiling registration dossiers according to country specific requirements in collaboration with other functions.
• Compile high quality eCTD sequences as required in the eCTD publishing tool
• Coordinate, review and proof-read responses to questions from authorities
• Evaluate changes for regulatory impact and filing requirements
• Ensure regulatory compliance by maintaining relevant data and documents in the Regulatory Database and Document Management System
• You report to stakeholders, including communication of approvals, worldwide marketing authorization status and other relevant information from Regulatory Databases
• You will play a key role in the submission management of new regulatory projects and in the life cycle management of existing licenses (EU and non-EU scope)
• Provide regulatory guidance and strategy to project teams involved in new product development
• Develop global regulatory strategy for assigned product(s) including submission strategy, timelines, recommendations regarding expansion plans and country requirements etc.
• Manage payments for regulatory procedures and annual fees
• Act as regulatory contact person for authorities, external partners and in-house functions
• Provide regulatory advice on proposed changes to life cycle management and pharmaceutical development activities
• Manage projects within the department as well as interdepartmental projects

• University degree in Natural Science
• At least 3-year RA experience in the pharmaceutical industry in an international environment
• In-depth knowledge of international regulatory requirements
• Ability to strategically plan, prioritise and manage multiple projects
• Attention to details and ability to deliver high quality regulatory documentation and submissions
• Solution-oriented way of working
• Strong communication skills to liaise with internal and external partners with different cultural backgrounds
• Full proficiency in MS Office, knowledge of SharePoint and an eCTD publishing tool 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 3.800.- based on full-time employment. Any potential overpayment depends on professional experience and qualifications.