Senior Specialist Regulatory Operations and System Support

About Viatris

Viatris is a global healthcare organization that uniquely bridges the gap between generic and branded medicines, providing holistic healthcare solutions worldwide. Our mission is to empower people globally to lead healthier lives at every stage. Supplying quality pharmaceuticals to about 1 billion patients annually, we impact diverse health needs from birth through chronic diseases. Our portfolio features iconic brand-name drugs, complex generics, and therapies spanning many therapeutic fields. We promote healthier communities through education, outreach, and enhanced treatment access. At Viatris, we cultivate a collaborative, courageous, and resilient culture where employees are empowered to thrive and make meaningful contributions.

Role Overview

The Senior Specialist in Regulatory Operations and System Support will be responsible for managing regulatory documentation and submissions related to XEVMPD/IDMP standards. This role requires coordination with both central teams and regional affiliates to monitor registration activities, maintain submission status, and ensure compliance with both internal and external regulatory standards. Additionally, this position supports projects that improve regulatory system efficiency and assists in managing broader project duties under the guidance of project leadership.

Key Responsibilities

• Maintain and update xEVMPD (Article 57) data using relevant software, ensuring quality and adherence to submission deadlines with health authorities.
• Handle queries from EMA and other agencies about xEVMPD/IDMP data promptly and accurately.
• Provide data for registration tracking aligned with regulatory mandates and internal procedures.
• Coordinate communications with Marketing Authorization (MA) Coordinators and third parties to ensure timely completion of required actions.
• Administer XEVMPD systems including user access and system updates.
• Conduct reconciliation of xEVMPD/IDMP data with affiliate inputs as necessary.
• Stay current on regulatory updates and facilitate their integration into systems and workflows.
• Manage SPOR PMS data submissions and maintain product portfolio information within the system.

Qualifications and Experience

• Bachelor's degree or equivalent in a relevant field, with 2 to 4 years of applicable experience; alternative combinations of education and experience will be considered.
• In-depth knowledge of EU regulations, particularly Article 57(2), SPOR, and IDMP frameworks.
• Experienced with xEVMPD data submissions, regulatory systems, and compliance requirements.
• Familiarity with Regulatory Information Management Systems (RIMS).
• Knowledge of Document Management Systems (DMS) and software like Adobe Acrobat and Microsoft Office suite.
• Experience liaising with regulatory authorities and stakeholders beyond core functional teams.
• Ability to collaborate effectively across multifunctional teams and projects.
• Strong organizational and time management skills to meet deadlines efficiently.
• Quick adaptability to new technologies and systems.
• Competence in numerical tasks such as calculating percentages, ratios, and rates.

Benefits

• Opportunities for career advancement.
• Initiatives supporting work-life balance.
• Bonus scheme participation.
• Health insurance coverage.
• Retirement pension plan.

Diversity and Sustainability

Viatris values diversity, inclusion, and sustainability as key components of its mission. We encourage applicants from diverse backgrounds and are committed to fostering a workplace that reflects equity and social responsibility.