Regulatory Affairs Manager, EMEA

Bausch Health; United States; Presencial; USD 120.000 - 180.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Regulatory submissions

Lifecycle management

Cross-functional collaboration

English communication

Educación

Pharmacy degree

Medicine degree

Biology/Life sciences degree

Descripción del empleo

Job Requisition ID: 15803

Regulatory Affairs Manager, EMEA (W/M)

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.

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.