Team Lead Global Regulatory Affairs Strategy (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 :

Team Lead Global Regulatory Affairs Strategy (f / m / d)

1190 Vienna Vollzeit Start : as of now

In this role, you will lead a regulatory affairs team and oversee strategy, submissions, and compliance for assigned products. Combining team leadership with hands-on regulatory expertise, you’ll ensure timely, high-quality submissions and effective lifecycle management across key therapeutic areas.

What Your Day To Day Will Look Like

• Manage, support, and develop direct reports within the regulatory team, setting objectives and evaluating performance.
• Act as regulatory lead for assigned products, coordinating submissions and ensuring compliance with EU and non-EU regulatory frameworks.
• Supervise the preparation and maintenance of marketing authorization dossiers in collaboration with R&D and internal stakeholders.
• Lead the lifecycle management of authorized products, including handling deficiency letters and change requests.
• Drive regulatory planning and ensure alignment with internal and external timelines and expectations.
• Maintain oversight of the regulatory quality management system (SOPs, work instructions, and departmental processes).
• Coordinate with internal departments and external partners (e.g., RA consultants) on submission-related matters.
• Oversee regulatory budget planning, invoice tracking, and consultancy fee processing.
• Stay updated through continuous training and participation in external regulatory events.
• Act as the administrator for Lorenz DocuBridge software for document and submission management.

Your  Qualifications and Experience

Our Offer

If you would like to work as a team player in an international environment and can identify with our values "Agile, Ambitious, Aligned, Accountable and Appreciative", then :