Generics (U.K.) Ltd.At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.Viatris empowers people worldwide to live healthier at every stage of life.We do so via: Access – Providing high quality trusted medicines regardless of geography or circumstance;Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and Partnership – Leveraging our collective expertise to connect people to products and services. Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment. For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world. The Role & What You Will Be Doing Manager Corporate Drug Regulatory Affairs responsible to support the pharmaceutical-regulatory of the assigned medicinal products and products worldwide. The jobholder is bound to the instructions of the responsible Team leader of Corporate Drug Regulatory Affairs.Key ResponsibilitiesEvery day, we rise to the challenge to make a difference and here's how the Manager Corporate Drug Regulatory Affairs role will make an impact: 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 authoritiesCollaboration 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 andpharmacovigilance 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 & ExperienceFor this role, we're looking for a candidate who has an effective combination of the following qualifications, skills and experiences:University degree in natural sciences, i.e. Biology, Chemistry or PharmacyAt least 3 years of experience in regulatory affairsKnowledge of essential regulatory requirements Ability to plan and execute regulatory projects globally Excellent communication skills, a real team playerExcellent skills in English languageKnowledge in 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 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. Diversity & Inclusion at Viatris At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit Sustainability at Viatris Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Viatris is an Equal Opportunity Employer.