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

Viatris; Lisboa; On-site; EUR 90,000 - 130,000; Full time

Job summary

Viatris is seeking a Regulatory Strategy Lead to drive EU regulatory strategy across a diverse medicinal product portfolio. You will lead submissions, ensure compliance, and coordinate with internal teams to align regulatory requirements with business goals.

Required: pharmacy/biotech background, 5+ years RA, fluent English, and strong interpersonal skills. The role entails close engagement with Health Authorities and partner organizations to enable timely market access.

Qualifications

• University degree in Pharmacy, Biotechnology or related pharma/medical science.
• Masters in Regulatory Affairs preferred.
• Fluent English in speaking and writing.
• 5+ years of Regulatory Affairs experience.
• Excellent interpersonal and collaboration skills.

Responsibilities

• Lead and support regulatory strategy and execution across European markets for diverse product portfolios.
• Ensure timely approvals, license maintenance and ongoing EU compliance.
• Manage product registrations via CP, DCP, MRP, and national pathways.
• Define robust European registration strategies for successful product launches.
• Collaborate with Clinical, QA, Legal and Commercial teams to integrate regulatory requirements.

Skills

Regulatory affairs

Fluent English

Interpersonal skills

Education

Pharmacy degree

Masters in RA

Job description

Company Overview

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 Every day

Key responsibilities for this role include:

• Regulatory Strategy Lead and support regulatory strategy and execution across European markets for a diverse portfolio of medicinal products (and/or other product classifications) including Generic, Established Brand, Innovative, and Value-Added products.
• Ensure timely approvals, maintenance of licences, and ongoing compliance with EU and national requirements.
• Manage a portfolio of products developed internally, externally (in partnership with Viatris) or via a Third Party/ Business Development (BD) Partner.
• Responsible for the development and implementation of European regulatory strategy that aligns with Global Regulatory Affairs objectives, partnering with Global Regulatory Affairs workstreams, maintain relations with internal/ external strategic partners through to stakeholders, provide regulatory guidance to other business functions, as well as Local European Regulatory Teams.
• Preparation and on-time submission of post-approval lifecycle activities, to include: Renewals, Variations (Administrative, CMC, Safety), Article 61(3) notifications and Country-specific notifications.
• Portfolio Oversight Maintain procedure oversight, lead and manage new product registrations through the Centralised Procedure (CP), Decentralised Procedure (DCP), Mutual Recognition Procedure (MRP), and National pathways, serving as the primary regional expert for these procedures.
• Provide Submission Strategic input, define and implement robust European registration strategies to ensure commercially successful product launches and rapid market access.
• Partner with Local Affiliate teams to ensure timely submission and execution of agreed filing strategies for Nationally-approved portfolio.
• Partnership/ Communication Work closely with internal departments such as Clinical, Quality Assurance, Legal, and Commercial teams to integrate regulatory requirements into business operations and product development.
• Liaise closely with internal functional areas to ensure alignment in all initiatives: Business Development, Regulatory CMC Sciences, Labelling, Pharmacovigilance, Product Launch, Artwork, Supply Chain and Quality colleagues.
• Liaise with Third Party/ Business Development (BD) Partners, establish effective communication channels and build positive relationships in order to progress regulatory activities.
• Health Authority Engagement Serve as a liaison with regulatory authorities (e.g. European Medicines Agency (EMA), national competent authorities), preparing submissions, and facilitating approvals for new products or changes to existing products.
• Proactively take opportunities to develop or enhance working relationships with Health Authorities to negotiate optimal outcomes for the business on product issues.
• Compliance & Risk Management Support with the assessment of regulation changes and their impact on operations.
• Support with the development of risk mitigation strategies.
• Investigate promptly, escalation and agree mitigation plan with Line Manager for any reported non-compliance issues.
• undefinedMentoring/ Training Provide expertise and skills in specialist area(s), where applicable, to support the department.
• Provide mentoring and training to team/ department in this specialist area, as required.
• Provide mentorship and guidance to less experienced team members, fostering a culture of regulatory excellence.

About Your Skills & Experience

• University degree (Pharmacy, Biotechnology, and/or other Pharma/Medical scientific background)
• Masters in RA is preferred
• Fluent English - speaking and writing
• 5+ years RA Experience
• Excellent interpersonal skills

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, 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.