Senior Manager, Regulatory Affairs page is loaded## Senior Manager, Regulatory Affairslocations: Northern Cross, Dublin, Irelandtime type: Tiempo completoposted on: Publicado hoyjob requisition id: R5665831 Mc Dermott Laboratories Limited En VIATRIS, vemos la atención médica no como es, sino como debería de ser.
Actuamos con valentía y estamos en una posición única para ser una fuente de estabilidad en un mundo de necesidades de atención médica en constante evolución.
Viatris ayuda a las personas de todo el mundo a vivir de manera más saludable en cada etapa de la vida.
Lo hacemos a través de: Acceso – suministrando medicamentos de confianza y de alta calidad independientemente de la geografía o las circunstancias; Liderazgo – promoviendo operaciones sostenibles y soluciones innovadoras para mejorar la salud del paciente; Colaboración – aprovechando nuestra experiencia común para conectar a las personas con productos y servicios.
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**The Senior Manager Global Branded CMC Strategy possesses CMC regulatory knowledge and quality expertise to independently prepare regulatory assessments & contribute to global regulatory strategies for projects across all aspects of drug development or manufacturing lifecycle and works to support the Upjohn portfolio.
Every day, we rise to the challenge to make a difference and here's how the **Senior Manager, Regulatory Affairs**role will make an impact:* Ensure global regulatory compliance with external requirements and internal quality procedures across all markets.* Apply sound regulatory judgment, strategic thinking, and business acumen to develop and implement global regulatory strategies.* Prepare, review, and deliver high-quality CMC submissions for new registrations, post-approval changes, renewals, and responses to agency queries.* Lead CMC activities for assigned projects, including submission planning, risk assessment, and regulatory timelines tracking.* Represent CMC on cross-functional project teams, ensuring alignment with scientific, technical, and regulatory criteria.* Maintain up-to-date regulatory documentation and systems, manage commitments, and ensure submission compliance.* Collaborate effectively with internal and external stakeholders, including Regulatory, Quality, R&D, and global/regional teams.* Serve as a technical and scientific resource for complex regulatory issues and provide mentoring to colleagues.* Support implementation of regulatory policies, procedures, and continuous improvement initiatives across CMC functions.* Build and maintain professional relationships with regulatory authorities and industry bodies to enhance regulatory success.* Contribute to CMC-related projects, training, and development programs, while modeling Viatris' values and behaviors.* Participate in external forums, trade groups, or industry conferences relevant to CMC functions as needed.**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:* Mandatory hands-on CMC authoring experience (initial registrations or post-approval variations)* Sufficient level of knowledge and solid understanding of the development and commercial activities and c GMP's required to assess technical, scientific and regulatory merits of CMC information, commitments and data to lead teams and/or project(s).* Advanced technical, functional, and industry knowledge to shape strategic direction of assigned project(s), reduce regulatory burden and improve regulatory flexibility commensurate with business needs.* Advanced knowledge of regulatory requirements and expectations, criteria for submission and approval globally and experience of interactions with regulatory authorities for projects.* Sound understanding and advanced knowledge of the principles, practices and concepts of regulatory CMC/ policy/ publishing disciplines and a working knowledge of the principles, practices, concepts and operations in other relevant disciplines.* Advanced skills in written & oral communications (mandatory).* Computer literacy with Microsoft Office Suite and Documentum-based applications.* Project Management skills* Ability to engage in the external regulatory and pharmaceutical environment.* Some experience serving as a Subject Matter Expert in specific relevant disciplines or as a resource for specific pharmaceutical science projects in specific regulatory domain(s).
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.
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**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 En Viatris, ofrecemos salarios competitivos, beneficios y un entorno inclusivo donde puede usar sus experiencias, perspectivas y habilidades para ayudar a generar un impacto en la vida de los demás.
Viatris es una compañía global del cuidado de la salud creada en 2020 a través de la combinación de Mylan y Upjohn, una división legada de Pfizer.
Al integrar las fortalezas de estas dos compañías, incluida nuestra fuerza laboral global de aprox.
45,000, nuestro objetivo es proporcionar acceso mejorado a medicamentos de calidad asequibles a pacientes de todo el mundo, independientemente de dónde vivan o de las circunstancias.
Creemos en el cuidado de la salud como debe ser: empoderamos a las personas de todo el mundo para que vivan de manera más saludable en cada etapa de la vida.
Debido a nuestra creencia firme de que un acceso mejorado permite una mejor salud, aprovechamos nuestra experiencia científica y de manufactura inmejorable, al igual que las capacidades comerciales comprobadas, para ofrecer a los pacientes medicamentos de calidad en el momento y en el lugar que los necesiten.
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