Regulatory Affairs Specialist at Viatris in Bucharest

Job description

BGP Products S.r.l. (Romania) 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 Every day, we rise to the challenge to make a difference, and here’s how the Regulatory Affairs Specialist role will make an impact: This position will lead the local medical team, ensure alignment and execution of local/regional medical strategy, collaborate with cross-functional teams and influence key healthcare stakeholders to drive meaningful impact for patients and the business. Regulatory Submissions & Product Lifecycle Management Ensure timely submission of marketing authorization applications for new, strategic, and line-extension products, including new indications, formulations, and strengths, in accordance with agreed registration strategies. Actively contribute to the development and implementation of regulatory registration strategies. Prepare and maintain high-quality regulatory documentation for marketing authorization applications, renewals, variations, safety updates, and notifications. Monitor and manage all stages of regulatory approval processes with the relevant health authorities. Coordinate responses to regulatory authority requests and ensure timely submission of additional documentation. Pricing & Market Access Support Participate in the preparation of documentation required for pricing approval applications for newly registered products in Romania. Collaborate with cross-functional teams to ensure timely achievement of product launch objectives. Regulatory Compliance Maintain thorough knowledge of marketing authorization dossiers and regulatory documentation for the company's product portfolio. Continuously update knowledge of local and international pharmaceutical regulations and regulatory requirements. Monitor changes in regulatory legislation, trends, and approval practices, and communicate relevant updates within the organization. Health Authority Interactions Establish and maintain effective working relationships with Romanian regulatory authorities and other relevant institutions. Serve as a key point of contact for regulatory matters related to the company's products. Labeling & Packaging Ensure that prescribing information and product information materials are accurate, up-to-date, and approved by both the company and local regulatory authorities. Support the development and review of packaging materials, labels, leaflets, and other product-related documentation in compliance with local regulations and company standards. Verify translations and adaptation of packaging components to ensure alignment with approved Romanian marketing authorizations. Regulatory Projects Manage regulatory aspects of change control processes affecting company products. Support completion of regulatory surveys and compliance initiatives. Contribu