Associate Regulatory Affairs Executive - Central Regulatory Affairs (CRA), Europe

1100 Mylan Pharmaceuticals Inc.; Lisboa; Presencial; EUR 28 000 - 38 000; Tempo integral

Resumo da oferta

Viatris is seeking an Associate Regulatory Affairs Executive - Central Regulatory Affairs (CRA), Europe. You will support regulatory submissions, maintain product licences, and ensure compliance across multiple European markets.

Ideal candidates have a degree in Pharmacy or Life Sciences, fluent English, and 0-2 years in regulatory affairs or a regulated healthcare environment. Collaboration with European affiliates is essential.

Qualificações

• Strong interest in regulatory affairs and the pharmaceutical industry.
• 0-2 years of regulatory affairs experience or regulated healthcare environment.
• Excellent communication and stakeholder management skills.

Responsabilidades

• Support regulatory activities for a diverse portfolio of pharmaceutical products across Europe.
• Assist with variations, renewals and other post-approval regulatory activities.
• Maintain marketing authorisations and regulatory compliance activities.
• Coordinate regulatory submissions with local affiliate teams.
• Maintain Regulatory Information Management (RIM) systems.
• Collaborate with Supply Chain, Quality, Finance and Product Launch teams.
• Support regulatory administration and fee management.

Conhecimentos

Regulatory Affairs

English fluency

Stakeholder management

Communication

Attention to detail

Formação académica

Pharmacy degree

Life sciences degree

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 a science graduate or early-career Regulatory Affairs professional looking to build experience within a global pharmaceutical organisation. You will work closely with European affiliates and cross-functional teams to support regulatory submissions, maintain product licences, and ensure compliance across multiple markets. Every day, we rise to the challenge to make a difference, and here’s how the Associate Regulatory Affairs Executive - Central Regulatory Affairs (CRA), Europe role will make an impact.

Key responsibilities for this role include:

• Support regulatory activities for a diverse portfolio of pharmaceutical products across Europe.
• Assist with the preparation and submission of variations, renewals, and other post-approval regulatory activities.
• Support the maintenance of marketing authorisations and regulatory compliance activities.
• Collaborate with local affiliate teams to coordinate regulatory submissions and national regulatory activities.
• Maintain Regulatory Information Management (RIM) systems and regulatory databases.
• Work cross-functionally with teams including Supply Chain, Quality, Finance, and Product Launch to ensure successful delivery of regulatory objectives.
• Support regulatory administration, fee management, and related compliance processes.

About Your Skills & Experience

• A degree in Pharmacy, Biotechnology, Life Sciences, or a related scientific discipline.
• Relevant industry experience will also be considered.
• Strong interest in Regulatory Affairs and the pharmaceutical industry.
• 0-2 years of Regulatory Affairs experience, or experience within a regulated healthcare/pharmaceutical environment.
• Excellent communication and stakeholder management skills.
• Strong organisational skills and attention to detail.
• Fluent English, both written and spoken.

At Viatris

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.