Manager Regulatory CMC Sciences (Injectables)

1100 Mylan Pharmaceuticals Inc.; Galway; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Health insurance

Pension

Bonus scheme

Career progression

Job summary

Viatris seeks a Regulatory Affairs professional to develop and implement global CMC regulatory strategies for injectable products. You will prepare and analyse global submissions, support variations and change controls, and liaise with regional regulatory, labeling, quality, and manufacturing teams.

The role requires a science degree and extensive experience in regulatory affairs, especially CMC for injectables, knowledge of US regulations, and proficiency with TrackWise and Documentum.

Qualifications

• Bachelor's degree (or equivalent) in a science-related discipline.
• Experience working within Regulatory Affairs in the pharmaceutical industry.
• Hands-on experience authoring post-approval CMC lifecycle management submissions.
• Hands-on Regulatory CMC experience supporting injectable products.
• Strong knowledge of global regulatory requirements, particularly US regulations.
• Experience with injectable, parenteral or combination product submissions.
• Excellent written and verbal communication skills, including preparation and review of regulatory documentation.
• Strong understanding of cGMP requirements, CFR, USP, Ph. Eur. and FDA guidance.
• Experience collaborating across Regulatory Affairs, Manufacturing, Supply Chain, Quality, Commercial, Medical and Legal functions.
• Proficiency with Microsoft Office applications and regulatory systems such as TrackWise and Documentum.
• Topra certification or RAC qualification preferred.

Responsibilities

• Develop and implement global CMC regulatory strategies for injectable products.
• Interpret and communicate regulatory requirements and provide risk-based regulatory guidance to stakeholders.
• Prepare, review and analyse global CMC submission documentation and lifecycle management activities.
• Support manufacturing sites with regulatory strategies and documentation for variations and supplements.
• Ensure regulatory compliance through effective management of CMC activities and change controls.
• Collaborate with regional regulatory, labelling, quality, supply chain and manufacturing teams to support submissions and agency interactions.
• Provide responses to health authority queries and participate in regulatory authority meetings and inspections as required.
• Act as a regulatory subject matter expert within cross-functional project teams.
• Mentor colleagues and contribute to knowledge sharing and capability development.
• Maintain awareness of emerging regulatory requirements and industry trends, communicating impacts to relevant stakeholders.

Skills

Regulatory Affairs

CMC

Injectables

Written & Verbal Communication

Project Management

US Regulations

Education

Bachelor's degree in a science-related discipline

Tools

TrackWise

Documentum

Job description

Mylan Teoranta 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

Every day, we rise to the challenge to make a difference and here's how the role will make an impact: Develop and implement global CMC regulatory strategies for injectable products. Interpret and communicate regulatory requirements and provide risk-based regulatory guidance to stakeholders. Prepare, review and analyse global CMC submission documentation and lifecycle management activities. Support manufacturing sites with regulatory strategies and documentation for variations and supplements. Ensure regulatory compliance through effective management of CMC activities and change controls. Collaborate with regional regulatory, labelling, quality, supply chain and manufacturing teams to support submissions and agency interactions. Provide responses to health authority queries and participate in regulatory authority meetings and inspections as required. Act as a regulatory subject matter expert within cross-functional project teams. Mentor colleagues and contribute to knowledge sharing and capability development. Maintain awareness of emerging regulatory requirements and industry trends, communicating impacts to relevant stakeholders.

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) in a science-related discipline. Experience working within Regulatory Affairs in the pharmaceutical industry. Hands-on experience authoring post-approval CMC lifecycle management submissions. Hands-on Regulatory CMC experience supporting injectable products. Strong knowledge of global regulatory requirements, particularly US regulations. Experience with injectable, parenteral or combination product submissions. Excellent written and verbal communication skills, including preparation and review of regulatory documentation. Strong understanding of cGMP requirements, CFR, USP, Ph. Eur. and FDA guidance. Experience collaborating across Regulatory Affairs, Manufacturing, Supply Chain, Quality, Commercial, Medical and Legal functions. Proficiency with Microsoft Office applications and regulatory systems such as TrackWise and Documentum. Strong project management skills and the ability to deliver to time, cost and quality standards. Previous people management experience would be advantageous. TOPRA certification or RAC qualification preferred.

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.

Viatris is a global healthcare company formed in 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer. By integrating the strengths of these two companies, including our global workforce, we aim to deliver increased access to affordable, quality medicines for patients worldwide, regardless of geography or circumstance. We believe in healthcare as it should be - empowering people worldwide to live healthier at every stage of life. Because of our unwavering belief that better access leads to better health, we leverage our best-in-class manufacturing and scientific expertise and proven commercial capabilities to bring quality medicines to patients when and where they need them.

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.