Job Description

Regulatory Affairs Manager, EMEA

Job Location: JeleniaGóra, POL | Rzeszów, POL | Warszawa, POL

Job Requisition ID: 15803

Join our general 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 i

📌 Regulatory Affairs Manager, EMEA (Pol)
🏢 Bausch Health
📍 Pol