Regulatory Affairs Manager CMC

Viatris; Dublin; On-site; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Excellent career progression机会

Work-life balance initiatives

Bonus scheme

Health insurance

Pension

Job summary

Viatris in Dublin seeks a Manager, Regulatory Affairs Brands CMC to independently prepare regulatory assessments across the lifecycle and help shape global regulatory strategies for the Upjohn portfolio.

You will develop robust CMC strategies, author submissions, mentor colleagues, and collaborate with R&D, Quality and Regulatory teams to ensure compliant, timely approvals.

Qualifications

• Bachelor's degree (or equivalent); a Master's degree is preferred.
• Significant pharmaceutical regulatory experience including R&D or QC.
• Hands-on CMC authoring experience (registrations or variations).
• Understanding of cGMPs and regulatory merits of CMC information.
• Advanced written and oral communication skills.
• Project management experience with Office tools and Documentum.
• Autonomous and able to handle complex problems independently.

Responsibilities

• Prepare regulatory assessments and contribute to global strategies for the drug lifecycle.
• Develop robust regulatory strategies and mitigate regulatory risks.
• Prepare and deliver CMC submissions and management plans globally.
• Serve as CMC representative on core project teams and coordinate responses.
• Track regulatory commitments and timelines across projects and markets.
• Coordinate CMC activities for registrations, post-approval changes, renewals, and line extensions.
• Provide technical guidance and mentor colleagues in CMC topics.
• Build relationships with local and global R&D, Quality, and Regulatory partners.

Skills

Pharma regulatory experience

CMC authoring

Regulatory strategy

Autonomous work

Project management

Education

Bachelor's degree (or equivalent)

Master's degree preferred

Tools

Microsoft Office

Documentum

Job description

McDermott Laboratories Limited

Viatris 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 Doing

The 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 procedures
• Developing robust regulatory strategies, leveraging technical and regulatory knowledge to mitigate risk
• Preparing and delivering high-quality CMC regulatory submissions and submission management plans for global regulatory agencies
• Serving as CMC representative on core project teams, assessing regulatory risks and shaping global regulatory strategies in line with regulatory, scientific and technical criteria
• Managing regulatory issues and tracking regulatory commitments and timelines across projects, products and markets with minimal supervision
• Authoring and/or coordinating CMC activities for new registrations, post-approval changes, renewals, annual reports and line extensions, including responses to Agency queries
• Acting as a technical and scientific resource, providing guidance on complex projects and mentoring colleagues within your area of expertise
• Building effective relationships with local and global partners across R&D, Quality, and Regulatory teams

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:

• Bachelor's degree (or equivalent); a Master's degree is preferred, and a combination of education and experience will be considered
• Significant pharmaceutical experience (Quality, Technical Services or R&D), including a number of years of pharmaceutical regulatory experience
• Hands-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 information
• Advanced written and oral communication skills
• Prior experience managing projects, with computer literacy in Microsoft Office Suite and Documentum-based applications
• Ability to work autonomously with minimal supervision, exercising independent judgment on complex, non-standardized problems

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 https://www.viatris.com/en/Careers/Diversity-and-Inclusion

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 https://www.viatris.com/en/about-us/corporate-responsibility

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.

Viatris is an Equal Opportunity Employer.