Senior Specialist Regulatory Key Initiatives

Benefits

Additional Information

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 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