Senior Regulatory Affairs Administrator - Central Regulatory Affairs (CRA)

1100 Mylan Pharmaceuticals Inc.; Lisboa; Presencial; EUR 42 000 - 56 000; Tempo integral

Resumo da oferta

Viatris is seeking a highly organized Regulatory Affairs Administrator for Europe to support regulatory activities across a portfolio of pharmaceutical products. The role emphasizes collaboration with local affiliate teams and maintaining compliance with European regulations.

Ideal candidates have an interest in Regulatory Affairs, strong communication skills, and the ability to manage multiple tasks in a regulated environment.

Qualificações

• Experience in Regulatory Affairs or a strong interest in the pharmaceutical regulatory field.
• Excellent organizational skills and attention to detail.
• Strong communication and stakeholder management abilities.
• Fluent English, both written and spoken.
• Regulatory affairs experience is advantageous but not essential.

Responsabilidades

• Support regulatory activities across a portfolio of pharmaceutical products in Europe.
• Assist with variations, renewals, and regulatory notifications.
• Coordinate administrative tasks to maintain marketing authorisations.
• Maintain and update Regulatory Information Management (RIM) systems.
• Collaborate with local affiliate teams on regulatory and operational activities.
• Support regulatory fee processing and related administrative duties.

Conhecimentos

Regulatory Affairs

English fluency

Organization

Stakeholder management

Communication

Ferramentas

RIM systems

Descrição da oferta de emprego

Mylan, Lda. 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 Story

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

This is an excellent opportunity for an organised and detail-oriented professional looking to develop a career in Regulatory Affairs within the pharmaceutical industry. You will support regulatory activities across Europe, helping to ensure medicinal products remain compliant with European and local regulatory requirements while working closely with internal stakeholders and affiliate teams. Every day, we rise to the challenge to make a difference, and here’s how the (Senior) Regulatory Affairs Administrator - Central Regulatory Affairs (CRA), Europe role will make an impact:

Key responsibilities for this role include:

• Support regulatory activities across a portfolio of pharmaceutical products throughout Europe.
• Assist with post-approval submissions including variations, renewals, and regulatory notifications.
• Coordinate administrative and compliance activities to support the maintenance of marketing authorisations.
• Maintain and update Regulatory Information Management (RIM) systems and databases.
• Work closely with local affiliate teams on regulatory and operational activities.
• Support regulatory fee processing, purchase orders, and other administrative tasks.
• Collaborate with cross-functional teams to ensure timely delivery of regulatory objectives undefined

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:

• Previous administrative experience, ideally within pharmaceuticals, healthcare, life sciences, or a regulated environment.
• A strong interest in Regulatory Affairs and the pharmaceutical industry.
• Excellent organisational skills and attention to detail.
• Strong communication and stakeholder management skills.
• Fluent English, both written and spoken.
• Regulatory Affairs experience is advantageous but not essential.

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.

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.

Viatris is a global healthcare company formed in 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer. By integrating the strengths of these two companies, including our global workforce, we aim to deliver increased access to affordable, quality medicines for patients worldwide, regardless of geography or circumstance.

We believe in healthcare as it should be – empowering people worldwide to live healthier at every stage of life. Because of our unwavering belief that better access leads to better health, we leverage our best-in-class manufacturing and scientific expertise and proven commercial capabilities to bring quality medicines to patients when and where they need them.