Senior Specialist Regulatory Operations and System Support page is loaded## Senior Specialist Regulatory Operations and System Supportlocations: Northern Cross, Dublin, Irelandtime type: Temps pleinposted on: Offre publiée aujourd'huijob requisition id: R5668663McDermott Laboratories LimitedViatris est une entreprise mondiale de la santé idéalement placée pour combler la division traditionnelle entre génériques et marques, combinant le meilleur des deux pour répondre de manière plus globale aux besoins de santé à l'échelle mondiale. Avec pour mission d'autonomiser les personnes du monde entier pour vivre en meilleure santé à chaque étape de la vie, nous offrons un accès à grande échelle, fournissant actuellement des médicaments de haute qualité à environ 1 milliard de patients dans le monde chaque année et touchant tous les moments de la vie, de la naissance à la fin de vie, des affections aiguës aux maladies chroniques. Nous avons été inclus dans plusieurs listes de récompenses qui démontrent l'impact que nous avons.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**The **Senior Specialist Regulatory Operations and System Support** will support the coordination and management of regulatory documentation and XEVMPD/IDMP submissions to health authorities. Working closely with the central organisation and local affiliates, the role involves tracking registration activities, managing submission status reporting, and ensuring both internal business needs and regulatory authority requirements are met. The successful candidate will also contribute to regulatory systems projects aimed at driving efficiency and effectiveness, while supporting broader project management activities under the direction of the project lead.Every day, we rise to the challenge to make a difference and here’s how the **Senior Specialist Regulatory Operations and System Support** role will make an impact:* Maintain xEVMPD (Article 57) data utilising XEVMPD software, ensuring data quality and compliance with submission timelines when submitting to Health Authorities.* Respond to EMA and other Health Authority queries relating to xEVMPD/IDMP data in a timely and accurate manner.* Provide registration tracking input in line with external and internal regulatory requirements and processes.* Coordinate regular communication with MA Coordinators and/or third parties to ensure outstanding actions are completed on time and in accordance with regulatory requirements.* Support XEVMPD system administration, including user management and system updates.* Perform reconciliation of xEVMPD/IDMP data with affiliates as required.* Monitor regulatory requirement updates and contribute to their implementation into relevant systems and processes.* Manage SPOR PMS data submissions and maintain the existing product portfolio within the system.**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:* Minimum of a Bachelor's degree (or equivalent) in a relevant discipline, with 2–4 years of relevant experience; a combination of education and experience will be considered.* Strong knowledge of EU regulations, specifically relating to Article 57(2), SPOR, and IDMP.* Proven expertise in xEVMPD data submissions, associated systems, and regulatory requirements.* Experience working with Regulatory Information Management Systems (RIMS).* Proficiency with Document Management Systems (DMS) and tools including Adobe Acrobat and the Microsoft Office Suite.* Experience engaging with health authorities and stakeholders outside of own functional area.* Demonstrated ability to work collaboratively as part of a team across multiple functions and projects.* Strong time management skills with the ability to prioritise and deliver within defined timelines.* Ability to quickly learn and adapt to new technologies and systems.* Proficient in numerical tasks including the calculation of percentages, ratios, and ratesAt 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 the following on top of a competitive salary:* 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. 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 visitChez Viatris, nous proposons des salaires compétitifs, des bénéfices et un environnement inclusif au sein duquel vous pouvez mettre à profit votre expérience, vos perspectives et vos compétences pour aider à avoir un impact positif sur la vie des autres.Viatris est une entreprise mondiale de services de santé créée en 2020 par la combinaison de Mylan et Upjohn, une division héritée de Pfizer. En intégrant les atouts de ces deux entreprises, y compris notre main-d’œuvre mondiale d’environ 45 000 personnes, nous visons à offrir un accès accru à des médicaments abordables et de qualité pour les patients du monde entier, indépendamment de la géographie ou des circonstances. Nous croyons aux services de santé comme ils devraient l’être, permettant aux personnes du monde entier de vivre plus sainement à chaque étape de la vie. Et parce que nous croyons fermement qu’un meilleur accès aux soins conduit à une meilleure santé, nous réunissons des compétences scientifiques et logistiques d’excellence, ainsi que des expertises commerciales éprouvées pour fournir des médicaments de qualité aux patients, où et quand ils en ont besoin.
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