Senior Manager, Core Labelling Strategy (12 month agency contract)

Viatris; Dublin; On-site; EUR 120,000 - 150,000; Full time

Benefits offered by this job

Health insurance

Pension

Bonus scheme

Job summary

Viatris is seeking a Senior Manager, Core Labelling Strategy in Ireland to lead global labelling development, maintain Core Labelling (CCDS) and US/EU documentation, and align cross-functional teams with regulatory strategy.

The role emphasizes ensuring scientific accuracy, regulatory acceptability, and proactive strategy across lifecycle stages, with opportunities to influence major submissions and external forums.

Qualifications

• For this role, a strong background in science and regulatory labelling is essential.
• Experience developing and maintaining global core labelling (e.g. CCDS) and major market labelling (USPI, EU SmPC).
• Experience supporting regulatory submissions (NDA/BLA/MAA) is preferred.
• Advanced degrees (MSc, PharmD, PhD) are advantageous but not required.
• Familiarity with TPL development, competitive labelling benchmarking and regulatory strategy.

Responsibilities

• Provide global regulatory labelling expertise to ensure compliant product information.
• Lead development and maintenance of Core Labelling and territorial labelling.
• Drive labelling strategy in partnership with Global Regulatory and cross-functional teams.
• Support Product Labelling Teams (PLTs) and engage with Global Labelling Committee when needed.
• Monitor competitor labelling and evolving regulatory requirements to inform strategy.
• Review promotional and non-promotional materials for CCDS alignment.
• Represent Viatris in external forums and discussions as appropriate.

Education

Bachelor's degree in Science, Medicine, Pharmacy, or related field

Regulatory labelling experience

Leadership in matrix environments

Regulatory submissions (NDA/BLA/MAA) experience

Knowledge of global labelling (SmPC/CCDS/USPI)

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

Provide global regulatory labelling expertise and leadership to ensure Product Information (labelling) for both existing and new Viatris products is developed, maintained, and implemented in compliance with applicable regulatory requirements.

The role is responsible for the development and maintenance of Core Labelling (including CCDS and associated patient information) and supports Global Ad Promo and Medical/Commercial material review and approval in line with company principles and procedures.

Additionally, the role contributes to strategic labelling activities across the product lifecycle, including Target Product Labelling (TPL), competitive labelling analysis, and regulatory precedent assessment to support global regulatory strategy and major submissions (e.g. USPI, EU SmPC).

All activities are performed in accordance with applicable SOPs, regulatory requirements, and company policies.

Every day, we rise to the challenge to make a difference and here’s how the Senior Manager, Core Labelling Strategy role will make an impact:

• Accountable for management and delivery of labelling activities across assigned products/portfolio.

• Leads development, preparation, review, and approval of global labelling documentation (e.g. TPL, CCDS, Core Patient Information) and territorial labelling (e.g. EU SmPC, USPI) based on clinical and non-clinical data.

• Leads or supports development of labelling strategy in partnership with Global Regulatory, ensuring alignment with overall regulatory strategy and business objectives.

• Contributes to development and maintenance of Target Product Labelling (TPL) to support early development, regulatory positioning, and cross-functional alignment.

• Establishes strong cross-functional partnerships with Regulatory Strategists, Medical, Safety, and Clinical teams to ensure proactive and effective labelling development.

• Leads labelling updates and development, critically evaluating supporting data to ensure scientific accuracy, clinical relevance, and regulatory acceptability.

• Assesses and reconciles deviations from Company Core Position (e.g. CCDS) and supports responses to Health Authority requests.

• Chairs or actively contributes to Product Labelling Teams (PLTs), ensuring appropriate cross-functional input. Escalates key issues to the Global Labelling Committee (GLC) as required.

• Maintains strong awareness of competitor labelling, evolving regulatory requirements, and external trends to inform labelling strategy.

• Manages complex regulatory and scientific labelling issues, balancing compliance, business needs, and risk.

• Contributes to interpretation and application of emerging regulatory guidelines impacting labelling.

• May represent Viatris in external forums (e.g. industry groups, EMA/FDA workshops).

• Reviews and approves promotional and non-promotional materials for alignment with CCDS and applicable codes and requirements.

• Reviews and advises on key scientific and regulatory documents (e.g. IB, protocols, CSR, PSURs, RMPs) as appropriate.

• Provides labelling expertise in cross-functional and regulatory team discussions.

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 Science, Medicine, Pharmacy, or related field with typically experience, including significant labelling experience.

• Demonstrated experience in development and maintenance of global core labelling (e.g. CCDS) and major market labelling (e.g. USPI, EU SmPC).

• Experience supporting regulatory submissions (e.g. NDA/BLA/MAA) preferred.

• Advanced degree (MSc, PharmD, PhD) is advantageous but not required.

• Experience in TPL development, competitive labelling benchmarking, and regulatory strategy support is an advantage.

• Regulatory experience with strong knowledge of global labelling across development and lifecycle management.

• Understanding of PLT and GLC governance frameworks and EU/US labelling requirements (SmPC, USPI, CCDS).

• Experience with TPL development and competitive labelling analysis.

• Experience supporting labelling for regulatory submissions in major markets (e.g. US, EU).

• Prior leadership experience or demonstrated ability to lead and influence others in a matrix environment.

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 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.