EMEA Regulatory Affairs Lead — Submissions & Strategy

Bausch Health; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

Bausch Health is seeking an experienced Regulatory Affairs Manager for the EMEA region to lead regulatory submissions, lifecycle management, and cross-functional collaboration across medical, QA, and CMC teams. You will drive regulatory strategy and contribute to market expansion while ensuring EU regulatory compliance.

You will oversee complex dossiers, maintain registrations, and work with Health Authorities to support business objectives within a dynamic, international environment.

Qualifications

• 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.

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.

Skills

Regulatory submissions

Lifecycle management

Cross-functional collaboration

English communication

Education

Pharmacy degree

Medicine degree

Biology/Life sciences degree

Job description

Bausch Health is seeking an experienced Regulatory Affairs Manager for the EMEA region to lead regulatory submissions, lifecycle management, and cross-functional collaboration across medical, QA, and CMC teams. You will drive regulatory strategy and contribute to market expansion while ensuring EU regulatory compliance.

You will oversee complex dossiers, maintain registrations, and work with Health Authorities to support business objectives within a dynamic, international environment.