Regulatory Affairs Officer (fixed term contract)Location: Northern Cross, Dublin, Ireland
Time Type: Full-time
Posted On: 19 days ago
Job Requisition ID: R5650208
About Viatris At Viatris, we see healthcare not as it is, but as it should be. We act boldly and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris enables people worldwide to live healthier at every stage of life through:
Access: Providing reliable, high-quality medicines regardless of geography or circumstances;Leadership: Promoting sustainable operations and innovative solutions to improve patient health;Partnership: Leveraging our collective expertise to connect people with 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.
The Role & What You Will Be Doing Supporting Viatris's mission to provide high-quality access to healthcare by assisting senior leaders with compliant registration of established products within one or more product types (OSD, Biologics, Injectables, Transdermal, API, etc.) throughout the product lifecycle within a given region (NA, EU, JA, NZ, ROW etc.).
Every day, we rise to the challenge to make a difference and here's how the Regulatory Affairs Officer role will make an impact:
Provide administrative support to meet general business needs.Interact in a highly professional manner with Regulatory Affairs team and external departments.Schedule meetings and facilitate conference calls as requested by management.Organize travel for management.Communicate with Health Authorities regarding general administrative tasks (e.g., slot dates, fee payments, etc.) and other non-technical, non-scientific communications.Execute regulatory activities, as directed, for product lifecycle management for one or more product types (OSD, Biologics, Injectables, Transdermal, API, etc.) within a specified region (NA, EU, JA, NZ, ROW etc.).Maintain general knowledge of regulations and guidance for one or more product types (Biologics, OSD, Injectables, API, etc.) within a specified region (NA, EU, JA, NZ, ROW etc.).Collaborate with the regulatory team to prepare submission documents.Ensure all documentation is in compliance with eCTD standards.Perform data entry to ensure regional regulatory compliance within regulatory databases and change management systems.Organize and maintain databases for regulatory use as directed by management.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:
High school diploma/GED/Higher secondary or equivalent.2-3 years of experience in a clerical or administrative role.Must possess organizational skills, time management skills, and attention to detail.Strong demonstrable capabilities in the use of software applications.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.
Benefits at Viatris 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. Some of our benefits include:
Excellent career progression opportunities.Work-life balance initiatives.Bonus scheme.Health insurance.Pension.Diversity & Inclusion 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.
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.
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