- Through liaison with GRA Policy, Regional & Country Regulatory teams, regular & attentive monitoring of agency websites and online tools, and review of agency queries and requests for information, coordinates the centralized collection of emerging regulatory intelligence and changing CMC regulatory guidance requirements across all Viatris product types and global markets for the purposes of adding to (populating) and maintaining the Viatris Regulatory Requirements Manager (RRM) tool.
- Organizes, leads and serves as the regulatory requirements change request reviewer in the RRM change control process for changes being requested to RRM content or inclusion of new country content in the system, and coordinates requests from stakeholders, provides input and consolidates comments pertaining to draft regulatory guidance documents.
- Assists in system validation activities for the RRM system, drives continuous improvement to the business process and supports global regulatory system integration / automation projects, and ensures a one-language approach and standardization of terminology & approach in defining regulatory requirements in RRM.
- Manages governance-related requests to country and regional regulatory leads of updates made to RRM, and informs/notifies users of changes on a regular basis.
- Assists with the management of content of CTD templates used in commercial and investigational submissions across global markets. Adds and maintains instructional text specific to market content requirements, using contemporary market & regional guidance documents and internationally harmonized consortium guidance documents (eg. ICH). Generates the necessary change notifications, content review discussions with departmental leadership, and template version control.
- Collaborates with various functional departments within Viatris to ensure a consistent and harmonized approach for the development and maintenance of templates, and develops and maintains templates per Viatris publishing style guides for bookmarking, hyperlinking, file naming, etc.
- Provides input into the development of submission content plans (SCPs) to provide baseline document requirements and guidance for required file names, titles, and electronic backbone locations for the documents.
- Reviews incoming HA correspondence and query letters to assess for trends and required updates to current practices and templates.
- Provides technical expertise to submissions content authors to meet the technical specifications for submissions documents, and leads and collaborates on initiatives with the potential to increase efficiencies and standardization across the Regulatory organization.
- Executes training related activities (e.g. functional, compliance-related, HR policies) & individual development plans. Participates in cross-disciplinary forums and learning opportunities, engages in Straight Talk & Listen exchanges, demonstrates and models adherence to all Viatris' behaviors & values, embraces & complies with Principles of Integrity, and participates, as required, in pharmaceutical industry conferences or serves externally as a representative to pharmaceutical trade group advisory committees relevant to CMC functions.
- Regulatory CMC knowledge (initial registrations or post-approval variations) - Minimum of 3+ years
- Minimum of 3+ years project management experience, working with matrixed & technical teams
- Understanding of current and emerging regulatory requirements & expectations to achieve submission approvals and shape internal Viatris policy and drive continuous system improvement.
- Technical, functional, and industry knowledge in shaping project strategy, reducing regulatory burden & improving regulatory flexibility across diverse therapeutic areas. Independently capable of executing activities across all aspects of drug development and commercial manufacturing product lifecycle.
- Possesses sound understanding of business expectations across partner lines, with proven ability to partner successfully with other Regulatory functions.
- Possesses system validation knowledge and experience.
- Excellent career progression opportunities
- Work-life balance initiatives
- Bonus scheme
- Health insurance
- Pension
Manager, Global Regulatory Requirements - Dublin, Ireland - Viatris
Description
McDermott Laboratories Limited 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 Manager, Global Regulatory Requirements & Dossier Standardization (Fixed Term Contract) role will make an impact:
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:
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:
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
At Viatris, we offercompetitivesalaries, benefitsandan 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.