EMEA Regulatory Affairs Lead (Hybrid)

Bausch Health Companies Inc.; Rzeszów; Hybrid; PLN 250,000 - 360,000; Full time

Benefits offered by this job

Health insurance

Job summary

Bausch Health Companies Inc. 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 drive regulatory submissions, lifecycle management, and cross-functional collaboration across medical, QA, and CMC teams to support regional market expansion. The role requires strong EU regulatory knowledge, excellent English, and a degree in Pharmacy, Medicine, Biology, Life Sciences, or related field.

Qualifications

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

Responsibilities

• Manage regulatory submissions and prepare CTD dossiers, including communication with Health Authorities and eCTD preparation.
• Lead lifecycle management activities 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.

Skills

Regulatory submissions

Lifecycle management

Cross-functional collaboration

eCTD preparation

Health Authority liaison

English proficiency

Regulatory strategy

Education

Degree in Pharmacy/Medicine/Life Sciences

Job description

Bausch Health Companies Inc. 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 drive regulatory submissions, lifecycle management, and cross-functional collaboration across medical, QA, and CMC teams to support regional market expansion. The role requires strong EU regulatory knowledge, excellent English, and a degree in Pharmacy, Medicine, Biology, Life Sciences, or related field.