Regulatory Affairs Specialist with German

For one of our clients, an international pharmaceutical company that has a regulatory affairs hub in Poland, we are looking for:

Regional Regulatory Affairs Specialist (DACH Region – Austria, Switzerland)
Location: Warsaw
Work Mode: Hybrid

Responsibilities:

• Manage post-approval changes and lifecycle management for products in the DACH region (Austria, Switzerland), ensuring compliance with local regulatory requirements.

• Monitor regulatory processes, including variation filings, renewals, and labeling updates, to ensure timely and accurate submissions.

• Prepare and review dossier documentation, including document translations and adaptations for local requirements.

• Support health authority (HA) interactions by coordinating document preparation and submission.

• Assist in the development of region-specific regulatory strategies, aligning global objectives with local requirements.

• Ensure the timely update of product information and labeling in accordance with local guidelines.

• Collaborate effectively with internal teams to ensure seamless execution of regulatory processes.

Requirements:

• University degree (Bachelor’s or Master’s) in health-related sciences (preferably pharmaceutical) or an equivalent qualification.

• At least 1 year of experience in regulatory affairs or a related field.

• German language skills at a B2/C1 level or higher (written and spoken).

• Fluency in Polish and English.

• Strong organizational skills and attention to detail.

• Ability to work independently and manage multiple tasks simultaneously.