EMEA Regulatory Affairs Manager – Submissions & Lifecycle

Bausch Health; Rzeszów; Hybrid; PLN 200.000 - 320.000; Vollzeit

Zusammenfassung

Bausch Health is seeking an experienced Regulatory Affairs Manager for the EMEA region, based in Warsaw, Rzeszów, or Jelenia Góra with a hybrid work model. You will manage regulatory submissions, lead lifecycle management, and collaborate with cross-functional teams across the region.

The ideal candidate has at least eight years in Regulatory Affairs, solid EU procedures knowledge (DCP, MRP, CP), experience with product registrations, and excellent English.

Qualifikationen

• Minimum 8 years of Regulatory Affairs experience in 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.

Aufgaben

• 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.

Ausbildung

Bachelor's degree in Pharmacy, Medicine, Biology, Life Sciences, or related field

Tools

EU regulatory procedures (DCP, MRP, CP)

Jobbeschreibung

Bausch Health is seeking an experienced Regulatory Affairs Manager for the EMEA region, based in Warsaw, Rzeszów, or Jelenia Góra with a hybrid work model. You will manage regulatory submissions, lead lifecycle management, and collaborate with cross-functional teams across the region.

The ideal candidate has at least eight years in Regulatory Affairs, solid EU procedures knowledge (DCP, MRP, CP), experience with product registrations, and excellent English.