Manager Corporate Drug Regulatory Affairs

McDermott Laboratories Limited

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally.

The Role & What You Will Be Doing

• Handling of marketing authorisation application procedures (e.g. new submissions, line extensions) worldwide, as well as registration maintenance activities (e.g. variations, renewals)
• 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 Documenten management system, Change Control System, Regulatory Information Management System, etc.

About Your Skills & Experience

• 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 languageKnowledge of standard EDV programs (e.g. MS-Office)
• Preferrable knowledge in common regulatory systems (e.g. DMS, CCS, RIMS)

At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you're excited about this role but your past experience doesn't fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.

Viatris is an Equal Opportunity Employer.