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

1100 Mylan Pharmaceuticals Inc.; Lisboa; Presencial; EUR 55 000 - 75 000; Tempo integral

Resumo da oferta

Viatris is seeking an experienced Regulatory Affairs professional to lead regulatory activities across Europe, collaborating with cross-functional teams and health authorities to ensure registrations and lifecycle management. The role requires strong communication and knowledge of European procedures.

You will support affiliate teams, maintain regulatory documentation, and contribute to regulatory strategy while ensuring compliance and timely submissions across the product portfolio.

Qualificações

• A degree in Pharmacy, Biotechnology, Life Sciences, or a related scientific discipline.
• 2–3 years of Regulatory Affairs experience within the pharmaceutical industry.
• Knowledge of European regulatory procedures and lifecycle management.
• A Master's qualification in Regulatory Affairs would be advantageous.
• Strong communication and stakeholder management skills.
• Excellent organisational skills and attention to detail.
• Fluent English, both written and spoken.

Responsabilidades

• Manage regulatory activities for a portfolio of pharmaceutical products across Europe.
• Prepare and submit regulatory applications, variations, renewals, and lifecycle management activities.
• Support new product registrations through European and national regulatory procedures.
• Collaborate with European affiliate teams to ensure successful implementation of regulatory strategies.
• Maintain regulatory databases and documentation to ensure ongoing compliance.
• Build strong relationships with internal stakeholders and external business partners.
• Support interactions with regulatory authorities and contribute to responses to health authority queries.
• Monitor regulatory developments and assess their impact on the product portfolio.

Conhecimentos

Regulatory Affairs

Stakeholder management

Regulatory submissions

Communication skills

Formação académica

Bachelor in Pharmacy or Life Sciences

Master's in Regulatory Affairs (advantageous)

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 exciting opportunity for an experienced Regulatory Affairs professional to play a key role in managing regulatory activities across Europe. You will work with cross-functional teams, affiliate partners, and health authorities to support product registrations, lifecycle management, and regulatory compliance. Every day, we rise to the challenge to make a difference, and here’s how the Regulatory Affairs Executive - Central Regulatory Affairs (CRA), Europe role will make an impact:

• Manage regulatory activities for a portfolio of pharmaceutical products across Europe.
• Prepare and submit regulatory applications, variations, renewals, and other lifecycle management activities.
• Support new product registrations through European and national regulatory procedures.
• Collaborate with European affiliate teams to ensure successful implementation of regulatory strategies.
• Maintain regulatory databases and documentation to ensure ongoing compliance.
• Build strong relationships with internal stakeholders and external business partners.
• Support interactions with regulatory authorities and contribute to responses to health authority queries.
• Monitor regulatory developments and assess their impact on the product portfolio.

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.
• 2-3 years of Regulatory Affairs experience within the pharmaceutical industry.
• Knowledge of European regulatory procedures and post-approval lifecycle management.
• A Master's qualification in Regulatory Affairs would be advantageous.
• Strong communication and stakeholder management skills.
• Excellent 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.

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.