Global Regulatory Affairs Manager: Drug Licensing Strategy

Viatris; Dublin; On-site; EUR 65,000 - 90,000; Full time

Job summary

Viatris is seeking a Manager Corporate Drug Regulatory Affairs in Dublin, Ireland to lead regulatory applications and ensure compliance across global markets. This role requires a strong educational background in natural sciences, excellent communication skills, and the ability to work within cross-functional teams.

You will handle various regulatory documentation and support quality assurance activities. Join Viatris for a chance to make a global impact on healthcare accessibility.

Qualifications

• University degree in natural sciences, i.e. Biology, Chemistry or Pharmacy.
• Knowledge of essential regulatory requirements.
• Ability to plan and execute regulatory projects globally.
• Excellent communication skills, a real team player.
• Excellent skills in English language.
• Knowledge of standard EDV programs (e.g. MS-Office).
• Preferable knowledge in common regulatory systems.

Responsibilities

• Handle marketing authorisation application procedures worldwide.
• Prepare and discuss licensing strategies with authorities.
• Collaborate in regional/global projects in cross-functional teams.
• Review and prepare regulatory documents.
• Coordinate quality documentation and clinical/non-clinical documentation.
• Support QA and pharmacovigilance activities.
• Use electronic systems for regulatory management.

Skills

Regulatory requirements knowledge

Project planning and execution

Excellent communication skills

Team player

Fluent English

Knowledge of standard EDV programs

Knowledge of regulatory systems

Education

University degree in natural sciences (Biology, Chemistry, Pharmacy)

Tools

MS-Office

Document management system

Change Control System

Regulatory Information Management System

Job description

Viatris is seeking a Manager Corporate Drug Regulatory Affairs in Dublin, Ireland to lead regulatory applications and ensure compliance across global markets. This role requires a strong educational background in natural sciences, excellent communication skills, and the ability to work within cross-functional teams.

You will handle various regulatory documentation and support quality assurance activities. Join Viatris for a chance to make a global impact on healthcare accessibility.