Global Regulatory Affairs Manager: Drug Approvals

1100 Mylan Pharmaceuticals Inc.; Dublin; On-site; EUR 85,000 - 120,000; Full time

Job summary

Viatris is seeking a Manager Corporate Drug Regulatory Affairs to lead global regulatory submissions and lifecycle maintenance for branded and generic products. You will drive licensing strategies, coordinate cross-functional teams and ensure compliance across regions.

The role requires a university degree in natural sciences, strong regulatory knowledge, excellent English communication, and experience managing complex regulatory projects worldwide.

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).
• Preferrable knowledge in common regulatory systems (e.g. DMS, CCS, RIMS).

Responsibilities

• Handling of marketing authorisation application procedures worldwide, as well as registration maintenance activities.
• Preparation and discussion of licensing strategies with national and international authorities.
• Collaboration in regional/global projects in cross-functional teams.
• Review, preparation, coordination and processing of regulatory documents (CTD-module 1).
• Review and coordination of quality documentation (CTD - module 3 / 2.3).
• Coordination of clinical and non-clinical documentation.
• Support of QA activities (e.g. change control, PQR), drug information and pharmacovigilance related activities (e.g. Risk Management Plans, Company Core Data Sheets, PSURs).
• Use of electronic systems like Document management system, Change Control System, Regulatory Information Management System, etc.

Skills

Regulatory knowledge

Regulatory planning

Communication

English

Regulatory systems

Education

University degree in natural sciences

Tools

MS Office

Job description

Viatris is seeking a Manager Corporate Drug Regulatory Affairs to lead global regulatory submissions and lifecycle maintenance for branded and generic products. You will drive licensing strategies, coordinate cross-functional teams and ensure compliance across regions.

The role requires a university degree in natural sciences, strong regulatory knowledge, excellent English communication, and experience managing complex regulatory projects worldwide.