Regulatory Affairs Manager, EMEA

Job description

Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates it—where your skills and values drive our collective progress and impact.

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. We are an Equal Opportunity Employer. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.