Manager, Regulatory Affairs Global CMC
1 month ago
Manager, Regulatory Affairs Global CMC page is loaded Manager, Regulatory Affairs Global CMC Postuler locations Northern Cross, Dublin, Ireland Ireland Remote Office time type Temps plein posted on Offre publiée aujourd'hui job requisition id R5643497 McDermott Laboratories Limited
Chez 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
Every day, we rise to the challenge to make a difference and here’s how the Manager, Regulatory Affairs Global CMC role will make an impact:
Ensure regulatory conformance and consistency globally and in compliance with external regulatory requirements and internal quality procedures.
Demonstrate regulatory knowledge and experience, balanced judgment, crisp decision-making, exemplary collaboration and business acumen, i.e., regulatory strategy development, regulatory submission quality, investigations, review of policy and quality standards
Develop robust regulatory strategies, leveraging both technical and regulatory knowledge, to mitigate risks.
Prepare and deliver high-quality CMC regulatory submissions & submission management plans for global regulatory agencies.
Execute using regulatory policies and operational processes for delivering the product portfolio.
Serve as CMC representative on a core project(s), manage project activities, assess regulatory risks and develop plans to develop global regulatory strategies for programs in accordance with regulatory, scientific and technical criteria.
Manage regulatory issues, maintain submission information in relevant CMC systems, track regulatory commitments & timelines for specific projects/products/markets with minimal supervision.
Present and articulate issues for resolution, communicating regularly with key stakeholders to ensure alignment and providing consultation as a scientific/technical resource for assigned projects, mentoring and sharing experience with colleagues.
Author and/or coordinate CMC activities for new registrations, post approval changes, renewals, annual reports and line extensions to meet filing requirements. Coordinate and contribute to responses to Agency queries and perform quality review of regulatory CMC submissions.
Serve as a technical and scientific resource and provide guidance for completion of difficult and complex projects.
Prioritize and independently complete assigned workload appropriately.
Develop effective relationships with local and global internal partners, i.e., R&D; Quality; Global, Country & Regional Regulatory Leads; other CMC lines.
Develop relationships with regulatory authorities to improve Viatris’ regulatory success.
Execute training related activities (e.g. compliance-related, HR policies) and individual development plans, participate in cross-disciplinary forums and learning opportunities, engage in Straight Talk and Listen exchanges, demonstrate and model adherence to all Viatris’ behaviors and values, embrace and comply with Principles of Integrity.
Manage and contribute to CMC-related projects, initiatives and actions.
Participate, as required, in pharmaceutical industry conferences or serve externally as a representative to pharmaceutical trade group advisory committees relevant to CMC functions.
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:
Minimum of a Bachelor's degree (or equivalent) and 4-7 years of experience. However, a combination of experience and/or education will be taken into consideration.
A minimum of 6 years pharmaceutical experience with relevant technical experience (Quality, Technical Services, R&D) and a minimum of 3 years pharmaceutical regulatory experience required.
Mandatory hands-on CMC authoring experience (initial registrations or post-approval variations) - Minimum of 2+ years
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).
Technical, functional, and industry knowledge to shape strategic direction of assigned project(s), reduce regulatory burden and improve regulatory flexibility commensurate with business needs.
Regulatory requirements and expectations, criteria for submission and approval globally and experience of interactions with regulatory authorities for projects.
Updating, interpreting, and applying global and regional CMC guidelines, along with the ability to contribute to global regulatory strategies by proactively discussing with partners.
Emerging awareness of new scientific or manufacturing technology.
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.
Benefits at 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. Some of our benefits include the following on top of a competitive salary:
Excellent career progression opportunities
Work-life balance initiatives
Bonus scheme
Health insurance
Pension
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
Chez 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.
About Us #J-18808-Ljbffr-
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