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

Viatris; Lisboa; Presencial; EUR 25 000 - 40 000; Tempo integral

Resumo da oferta

Viatris seeks a Regulatory Affairs Associate to support a diverse European portfolio from its Lisbon office. This early‑career role offers exposure to submissions, renewals, and licensing activities across multiple markets in a global pharmaceutical company.

You will work with European affiliates and cross‑functional teams to maintain compliance, coordinate national submissions, and manage regulatory databases, contributing to efficient, compliant product launches and lifecycle management.

Qualificações

• Degree in Pharmacy, Biotechnology, Life Sciences or related field.
• 0–2 years in Regulatory Affairs or regulated healthcare environment.
• Strong communication and stakeholder management skills.
• Excellent organizational skills and attention to detail.
• Fluent English (written and spoken).

Responsabilidades

• Support regulatory activities for a diverse portfolio across Europe.
• Assist with preparation and submission of variations, renewals, and post-approval activities.
• Maintain marketing authorisations and regulatory compliance.
• Coordinate regulatory submissions with local affiliate teams.
• Keep Regulatory Information Management (RIM) systems up to date and accurate.
• Collaborate with cross-functional teams to meet regulatory objectives.

Conhecimentos

Regulatory Affairs

Communication

Stakeholder management

Attention to detail

Organization

Fluent English

Formação académica

Pharmacy

Biotechnology

Life Sciences

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

For this role, we're looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• 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, 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.

A t Viatris, we offer competitive salar ies , 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.