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, Viatris provides 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.
Viatris's 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.
The Role & What You Will Be Doing
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.
•Contribute to continuous improvement of regulatory processes and systems.
About Your Skills & Experience
Qualifications & Experience
•University degree in Pharmacy, Life Sciences, Medicine, Chemistry, or a related field.
•3-5 years experience in Regulatory Affairs within the pharmaceutical industry.
•Good understanding of pharmaceutical legislation, marketing authorization procedures, and lifecycle management.
•Experience interacting with health authorities and preparing regulatory submissions is highly desirable.
•Strong knowledge of Romanian regulatory requirements; knowledge of European regulatory procedures is an advantage.
•Excellent organizational and project-management skills.
•Strong attention to detail and ability to manage multiple priorities.
•Proficiency in English and Romanian, both written and spoken.
•Advanced knowledge of Microsoft Office applications.
Competencies
•Strong analytical and problem-solving skills.
•Effective communication and stakeholder-management abilities.
•Ability to work independently and collaboratively in a cross-functional environment.
•Proactive mindset with a continuous improvement approach.
•High level of integrity and commitment to compliance.
Why 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. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.
