Director - Regulatory Affairs CMC - Ireland - Viatris

Description

Director - Regulatory Affairs CMC page is loaded

Director - Regulatory Affairs CMC

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 Director - Regulatory Affairs CMC will make an impact:

Key responsibilities for this role include:

• Cultivates sustainable and effective relationships across a network of stakeholders, partners and customers to drive and establish aligned approaches to regulatory strategies and/or policies.
• Interprets CMC regulatory requirements, develops strategies (including novel approaches), assesses risks and develops contingency proposals.
• Uses technical and scientific knowledge in the preparation and analysis of global CMC submission documentation and maintenance of product compliance and management of CMC change control.
• Ensures all CMC regulatory activities are executed effectively and efficiently, and in compliance with external regulatory requirements & internal quality procedures.
• Serves as a liaison with regulatory agencies for specific topics and providing oversight for the fulfillment of agency commitments and providing responses to agency queries.
• Presents and articulates issues for resolution, communicating regularly with key stakeholders to ensure alignment, providing consultation as a scientific/technical resource within the department/cross-functional and therapeutic teams for assigned projects, mentoring and sharing experience with colleagues.
• Manages, leads and contributes significantly to Upjohn projects and initiatives within cross-functional project teams.
• Serves on governance and steering committees.
• Executes training related activities (e.g. compliance-related, HR policies) and 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 and values, embraces and complies with Principles of Integrity.
• Participates, as required, in pharmaceutical industry conferences or serves externally as a representative to pharmaceutical trade group advisory committees relevant to CMC functions.
• Manages CMC responses in response to MedInfo queries.
• May serve as the global CMC lead in Due Diligence exercises.

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). A Master's degree (or equivalent) preferred. A minimum of 8-12 years pharmaceutical experience with relevant technical experience (Quality, Technical Services, R&D) and a minimum of 6 years pharmaceutical regulatory experience required. A combination of experience and/or education will be taken into consideration.
• Mandatory hands-on CMC authoring experience (initial registrations or post-approval variations) - Minimum of 5+ years.
• Minimum of 5+ years people and/or project management experience, serving as a leader of matrixed and technical teams.
• High level of knowledge of development & commercial activities and cGMP's to assess technical, scientific & regulatory merits of CMC information, commitments and data to lead teams and/or complex projects.
• Extensive technical, functional, and industry knowledge in shaping project strategy, reducing regulatory burden and improving regulatory flexibility across global markets and diverse therapeutic areas. Independently capable of executing activities related to complex projects across all aspects of drug development and commercial manufacturing product lifecycle.
• Advanced understanding of current and emerging regulatory requirements and expectations, criteria for submission and approval globally, and experience in leading negotiations and interactions with regulatory authorities for projects and/or policy initiatives.
• Possesses sound understanding of business expectations across partner lines, with proven ability to partner successfully with other Regulatory functions, Manufacturing and Supply Chain, Quality, Safety, Medical, Commercial, Legal and senior stakeholders to achieve objectives.
• Computer literacy with Microsoft Office Suite and Documentum-based applications.
• Demonstrated commitment and dedication to scientific and regulatory integrity and quality compliance.
• Demonstrated strategic thinking and ability to integrate strategies into actionable plans.

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