Regulatory Officer (15 months’ fixed term contract, external employment)

Mylan EOOD

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We do so via: 

Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and 
Partnership – Leveraging our collective expertise to connect people to products and services. 
 

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 Officer (15 months’ fixed term contract, external employment) role will make an impact:  

•  Provide administrative and operational support to the Affiliate Regulatory Affairs team in all regulatory activities.
• Assist in the preparation, compilation, and formatting of regulatory dossiers for submissions to health authorities.
• Support the maintenance of Marketing Authorizations throughout their lifecycle, including variations, renewals, and related documentation.
• Maintain and update regulatory systems and databases to ensure accuracy and compliance with corporate and local standards.
• Organize, archive, and manage regulatory documentation in accordance with SOPs and best practices, ensuring files are auditable and easily retrievable.
• Track and monitor the status of submissions and approvals, maintaining clear records and timelines.
• Assist in the review and preparation of product labeling and patient information leaflets for compliance with regulatory requirements.
• Support the handling of regulatory-related inquiries from internal teams and external stakeholders.
• Coordinate with cross-functional teams to ensure timely delivery of regulatory documents and information.
• Monitor local regulatory guidelines and assist in implementing necessary updates to maintain compliance.
• Provide logistical and documentation support for audits, inspections, and regulatory meetings.
• Contribute to continuous improvement initiatives for regulatory processes and systems.
• Support internal handling of Periodic Safety Update Reports (PSUR) and assist in the local implementation of Risk Management Plans.
• Assist in the regulatory review and approval of local promotional materials under supervision.
• Maintain current knowledge of local and EU regulatory requirements applicable to medicinal products, medical devices, and food supplements.
• Ensure adherence to Viatris Corporate Policies, Procedures, and Guidelines, as well as local regulatory requirements.

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:  

•  University degree, preferably in Medicine, Pharmacy, Chemistry, Biology or Chemical Engineering
• Professional experience in a similar regulatory role is beneficial
• Knowledge of Bulgarian and international regulatory procedures is beneficial
• Ability to handle multiple priorities simultaneously and work under strict deadlines
• Strong interpersonal skills and an outgoing personality to facilitate communication and liaison with officials
• Proficiency in MS Word, MS Excel, and MS PowerPoint
• Excellent organizational skills and attention to detail
• Ability to work independently and as part of a team in a fast-paced environment

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. 

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. 

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 https://www.viatris.com/en/Careers/Diversity-and-Inclusion  

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 visit https://www.viatris.com/en/about-us/corporate-responsibility  

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. 

Viatris is an Equal Opportunity Employer.