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](https://www.viatris.com/en/careers) that demonstrate the impact we are making.
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.
Why Viatris?
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. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.
Diversity & Inclusion at Viatris
At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare, not as it is, but as it should be. If you would like to know more about what diversity, equity, and inclusion means to us, please visit [https://www.viatris.com/en/Careers/Diversity-and-Inclusion](https://www.viatris.com/en/Careers/Diversity-and-Inclusion)
Sustainability at Viatris
Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit [https://www.viatris.com/en/about-us/corporate-responsibility](https://www.viatris.com/en/about-us/corporate-responsibility)
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 whose mission is to empower people worldwide to live healthier at every stage of life. We meet the needs of patients around the world by acting decisively with ingenuity and resolve. Whether we're developing new medicines, working to maintain a resilient supply of needed therapies, or pursuing bold innovation, we strive to deliver solutions that are effective at scale and built to endure. We're purpose-built to make an impact with a broad portfolio that spans generics, value-added medicines, established brands, and innovative medicines that address areas of significant unmet need. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai, and Hyderabad, India.
