Overview
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. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.
We have been included on number of award lists that demonstrate the impact we are making.
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
Every 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 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
For 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 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)
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.
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 https://www.viatris.com/en/Careers/Diversity-and-Inclusion
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 https://www.viatris.com/en/about-us/corporate-responsibility
Viatris is an Equal Opportunity Employer.
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