Assistant – Regulatory Affairs & Medical Compliance (M/W/D)

This position is a support and assistant role with a strong focus on administrative, coordination, and operational tasks within the Regulatory Affairs and Medical Compliance context. I

t is ideal for candidates who enjoy structured, detail‑oriented work and supporting teams in their daily activities within a regulated environment.

General Job Responsibilities:

Conducts activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role. Completes all required training on the AZ Code of Conduct and supporting Policies and Standards on time, reports any potential issues of non-compliance.

Main tasks:

Acts as a super user for the Regulatory Sharepoints (maintenance and further development).

Prepares the

Fachinformation, Gebrauchsinformation and Fachkurzinformation

out of the approved text for the cross functional teams

Handles and documents information on parallel imported products.

Assists the RA team with generic administrative tasks incl. Purchase Orders and vendor management, meeting organisation, travel and training, etc.

Supports the regulatory team in all activities related to budget monitoring and control.

Supports the Regulatory team in all the activities related to the registration and maintenance of products, as well in GRP (Good Regulatory Practice), in compliance with all local and global codes, standards and procedures.

Supports the maintenance/revision and creation of RA SOPs and the Business Continuity Plan (BCP). Organize the yearly testing of the BCP.

Oversees, organises and manages the Regulatory Affairs digital and hardcopy archive, ensuring appropriate archiving according to the retention guideline (acts as the RA team Archive Coordinator).

Supports the RA team and the Medical Team/Medical Director in the quality assurance and business compliance area (e.g. due diligence processes).

Cooperation and mutually backing up with the Medical Affairs Assistant for essential tasks during planned and unplanned absences and workload, by regularly align and exchange to ensure a consistent way of working.

Supports Compliance Business Partner with the Quarterly Compliance Monitoring activities for the MC.

Experience & Skills Required:

Completed secondary education (Matura / Abitur, International Baccalaureate, or equivalent).

A Bachelor’s degree in Science is nice to have, but not required.

Approximately 2–3 years of experience in an administrative, coordination, or support role, ideally within a regulated, healthcare, or corporate environment.

Very good command of German and English (spoken and written).

Strong organizational skills with the ability to manage multiple routine tasks and deadlines in a structured way.

Careful, reliable, and detail‑oriented working style.

Strong willingness to learn and to support teams in day‑to‑day operations.

Good user skills in MS Office (Word, Excel, PowerPoint).