Senior Regulatory Affairs Assistant (12 month fixed-term contract) Locations: Northern Cross, Dublin, Ireland
Time Type: Full Time
Posted on: More than 30 days ago
Job Requisition ID: R5649292
About Viatris En VIATRIS, vemos la atención médica no como es, sino como debe ser. Actuamos con valentía y estamos en una posición única para ser una fuente de estabilidad en un mundo de necesidades de atención médica en evolución. Viatris permite a las personas de todo el mundo vivir de manera más saludable en cada etapa de la vida.
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 Senior Regulatory Affairs Assistant 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 regulatory team to prepare submission documents.Collaborate with regulatory team to ensure all documentation is in compliance with eCTD standards.Perform data entry to ensure regional regulatory compliance within regulatory databases and change management system.Organize and maintain databases for regulatory use as directed by management.About Your Skills & Experience High school diploma/GED/Higher secondary or equivalent.2-3 years of experience in a clerical or administrative role.Must possess organization skills, time management skills, and attention to detail.Strong demonstrable capabilities in the use of software applications.Benefits at Viatris Excellent career progression opportunities.Work-life balance initiatives.Bonus scheme.Health insurance.Pension.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.
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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