Senior Manager, Regulatory CMC Strategy page is loaded## Senior Manager, Regulatory CMC Strategylocations: Northern Cross, Dublin, Irelandtime type: Temps pleinposted on: Offre publiée aujourd'huijob requisition id: R*******McDermott Laboratories LimitedChez Viatris, nous envisageons la santé non pas telle qu'elle est mais telle qu'elle devrait être.
Nous agissons avec courage et notre positionnement unique est source de stabilité dans un monde où les besoins en matière de santé sont en constante évolution.
Viatris permet à chacun dans le monde entier de vivre en meilleure santé à chaque étape de sa vie.
Via trois axes majeurs:*Accès*: En fournissant des médicaments de haute qualité et reconnus, quels que soient le lieu de résidence ou la situation de chaque patient.
*Leadership*: En favorisant l'évolution de nos activités de façon durable et le développement de solutions innovantes pour améliorer la santé des patients.
*Partenariat*: En valorisant notre expertise collective afin de donner accès à tous à nos produits et 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**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 Global Branded CMC Strategy** 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 cGMP'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 visitChez Viatris, nous proposons des salaires compétitifs, des bénéfices et un environnement inclusif au sein duquel vous pouvez mettre à profit votre expérience, vos perspectives et vos compétences pour aider à avoir un impact positif sur la vie des autres.Viatris est une entreprise mondiale de services de santé créée en **** par la combinaison de Mylan et Upjohn, une division héritée de Pfizer.
En intégrant les atouts de ces deux entreprises, y compris notre main-d'œuvre mondiale d'environ ****** personnes, nous visons à offrir un accès accru à des médicaments abordables et de qualité pour les patients du monde entier, indépendamment de la géographie ou des circonstances.
Nous croyons aux services de santé comme ils devraient l'être, permettant aux personnes du monde entier de vivre plus sainement à chaque étape de la vie.
Et parce que nous croyons fermement qu'un meilleur accès aux soins conduit à une meilleure santé, nous réunissons des compétences scientifiques et logistiques d'excellence, ainsi que des expertises commerciales éprouvées pour fournir des médicaments de qualité aux patients, où et quand ils en ont besoin.
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