Regulatory Affairs Manager CMC

1100 Mylan Pharmaceuticals Inc.; Leinster; On-site; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Bonus scheme

Health insurance

Pension

Career progression opportunities

Job summary

Viatris is seeking a Manager, Regulatory Affairs Brands CMC to independently prepare regulatory assessments and contribute to global regulatory strategies across the drug development and manufacturing lifecycle. You will deliver high-quality CMC submissions, manage timelines, and mentor others while collaborating with R&D, Quality, and Regulatory teams.

The role emphasizes autonomous work, regulatory risk assessment, and global conformance to CGMPs as part of advancing products from development

Qualifications

• Significant pharmaceutical regulatory experience.
• Experience with CMC authoring for registrations or variations.
• Strong written and oral communication skills.

Responsibilities

• Prepare regulatory assessments and contribute to global strategies.
• Develop robust regulatory strategies and risk mitigation.
• Prepare and deliver CMC submissions and management plans.
• Serve as CMC representative on core project teams.
• Manage regulatory issues and timelines across projects.

Skills

Regulatory writing

CMC authoring

Project management

Regulatory strategy

Communication

Microsoft Office

Documentum

Autonomous work

Education

Bachelor's degree

Master's degree (preferred)

Tools

Documentum

Microsoft Office

Job description

McDermott Laboratories LimitedViatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.We have been included on number of award lists that demonstrate the impact we are making.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 DoingThe Manager, Regulatory Affairs Brands CMC will independently prepare regulatory assessments and contribute to global regulatory strategies across the drug development and manufacturing lifecycle, supporting the Upjohn product portfolio.Every day, we rise to the challenge to make a difference and here’s how the Manager, Regulatory Affairs Brands CMC role will make an impact:Ensuring regulatory conformance and consistency globally, in compliance with external regulatory requirements and internal quality proceduresDeveloping robust regulatory strategies, leveraging technical and regulatory knowledge to mitigate riskPreparing and delivering high-quality CMC regulatory submissions and submission management plans for global regulatory agenciesServing as CMC representative on core project teams, assessing regulatory risks and shaping global regulatory strategies in line with regulatory, scientific and technical criteriaManaging regulatory issues and tracking regulatory commitments and timelines across projects, products and markets with minimal supervisionAuthoring and/or coordinating CMC activities for new registrations, post-approval changes, renewals, annual reports and line extensions, including responses to Agency queriesActing as a technical and scientific resource, providing guidance on complex projects and mentoring colleagues within your area of expertiseBuilding effective relationships with local and global partners across R&D, Quality, and Regulatory teamsAbout Your Skills & ExperienceFor this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:Bachelor's degree (or equivalent); a Master's degree is preferred, and a combination of education and experience will be consideredSignificant pharmaceutical experience (Quality, Technical Services or R&D), including a number of years of pharmaceutical regulatory experienceHands-on CMC authoring experience (initial registrations or post-approval variations)Solid understanding of development and commercial activities and cGMPs required to assess the technical, scientific and regulatory merits of CMC informationAdvanced written and oral communication skillsPrior experience managing projects, with computer literacy in Microsoft Office Suite and Documentum-based applicationsAbility to work autonomously with minimal supervision, exercising independent judgment on complex, non-standardized problemsAt 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 ViatrisAt 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 opportunitiesWork-life balance initiativesBonus schemeHealth insurancePensionDiversity & Inclusion at ViatrisAt 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 https://www.viatris.com/en/Careers/Diversity-and-InclusionSustainability at ViatrisCorporate 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 https://www.viatris.com/en/about-us/corporate-responsibilityAt 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.Viatris is an Equal Opportunity Employer.