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, we rise to the challenge to make a difference, and here’s how the Regulatory Affairs Manager - Central Regulatory Affairs (CRA), Europe role will make an impact:
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, escalate and agree mitigation plan with Line Manager for any reported non-compliance issues.
- undefinedMentoring/ TrainingProvide 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 & ExperienceFor this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences: University degree (Pharmacy, Biotechnology, and/or other Pharma/Medical scientific background)Masters in RA is preferredFluent English - speaking and writing5+ years RA ExperienceExcellent 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, 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.