Regulatory Affairs Manager, EMEA

Regulatory Affairs Manager, EMEA (W/M)

Location: Warsaw / Rzeszów / Jelenia Góra (hybrid model)

We are looking for an experienced Regulatory Affairs professional to join our regional team in a role with significant business impact. This position combines responsibility for key regulatory activities with involvement in strategic projects and international collaboration across the EMEA region.

Key Responsibilities

• Manage regulatory submissions and prepare CTD dossiers, including communication with Health Authorities and eCTD preparation.
• Lead lifecycle management activities (variations, renewals, and maintenance) for a portfolio of medicinal products.
• Participate in regional projects and market expansion initiatives, including Due Diligence activities.
• Support regulatory strategy development and collaborate with cross-functional teams, including Medical, QA, and CMC.
• Provide expert Regulatory Affairs guidance and support to internal stakeholders.

Requirements

• Minimum 8 years of Regulatory Affairs experience within the pharmaceutical industry.
• Solid knowledge of EU regulatory procedures (DCP, MRP, CP, and National Procedures).
• Proven experience in product registrations and lifecycle management.
• Excellent command of English, both written and spoken.
• Degree in Pharmacy, Medicine, Biology, Life Sciences, or a related field.

Nice to Have

• Experience in regional or multi-country regulatory projects.
• Knowledge of EMEA markets outside the European Union.
• Experience in Due Diligence projects or portfolio expansion initiatives.

What We Offer

• Opportunity to work on complex international projects.
• A role within a regional Regulatory Affairs hub, collaborating with diverse stakeholders across multiple markets.
• Exposure to strategic regulatory initiatives and business-critical activities.