Senior Specialist Regulatory Key Initiatives

Senior Specialist Regulatory Key Initiatives page is loaded Senior Specialist Regulatory Key Initiativeslocations: Northern Cross, Dublin, Irelandtime type: Temps pleinposted on: Offre publiée il y a 4 joursjob requisition id: RMcDermott 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, Global Regulatory Operations key will be responsible for utilizing their SME Regulatory knowledge to stay proactively informed of key regulatory initiatives across the globe, with a focus on pan European regulations. This will include a detailed impact and change management assessment on Regulatory business processes and systems to ensure that they are fit for purpose and changes are clearly communicated to all those impacted. Examples of key initiatives include eCTD 4.0, ePI, and IDMP.Every day, we rise to the challenge to make a difference and here's how the Senior Specialist, Regulatory Key Initiatives role will make an impact: Monitor and interpret global regulatory initiatives, with a strong focus on EU regulations (e.g. IDMP, eCTD 4.0, SPOR), ensuring the organisation remains compliant and informed. Lead cross-functional collaboration to identify data owners, improve data governance, and support IDMP implementation. Act as a subject matter expert (SME) on regulatory data, partnering with stakeholders to define, source, and maintain high-quality data, including establishing QC processes. Drive data management and enrichment activities, including populating IDMP templates and supporting internal RIM systems and external databases (e.g. EMA PMS). Identify, prioritise, and resolve data discrepancies, proposing solutions and ensuring visibility through appropriate escalation. Develop and improve business processes and SOPs, ensuring clear ownership (RACI), efficient workflows, and regulatory compliance. Support system and process improvements within RIM and related platforms, aligning with evolving regulatory requirements. Contribute to change management and training initiatives, supporting adoption of new processes, systems, and regulatory standards. Collaborate with Regulatory Operations, Master Data, and other teams to ensure data alignment, consistency, and integration across systems. 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: Bachelor's degree (or equivalent) with pharmaceutical industry experience, preferably in Regulatory Affairs or Regulatory Operations. Strong knowledge of EU regulatory frameworks, including EMA procedures, XEVMPD, and working knowledge of IDMP and SPOR. Experience with Regulatory Information Management (RIM) systems and understanding of the eCTD structure. Ability to interpret complex regulatory and technical documentation, including labelling (e.g. SmPC) and eCTD modules. Strong organisational skills, with the ability to manage multiple projects and deadlines simultaneously. Comfort working with complex systems and IT tools, including document and data management platforms. Excellent attention to detail and a proactive, continuous learning mindset. Strong collaboration and communication skills, with the ability to work cross-functionally and present complex information clearly. Proficiency in Microsoft Word and Excel; experience with document management systems is advantageous.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 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 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.