Manager, Core Labeling Strategy

1100 Mylan Pharmaceuticals Inc.; Washington, Northern (District of Columbia, KY); Hybrid; USD 78,000 - 152,000; Full time

Job summary

Viatris is seeking a Manager, Core Labeling Strategy to drive global core labelling development and maintenance across product lifecycles. The role requires leadership in CCDS and patient information, with collaboration across Regulatory, Medical, Safety, and Commercial teams to ensure compliant labelling for USPI, EU SmPC, and other markets.

The position emphasizes strategic labelling initiatives, adherence to SOPs, and proactive management of regulatory expectations, while representing Viatris

Qualifications

• Bachelor’s degree in Science, Medicine, Pharmacy, or related field with typically 3-5 years of experience, including significant labelling experience.
• Experience developing and maintaining global core labelling (e.g. CCDS) and major market labelling (e.g. USPI, EU SmPC).
• Experience supporting regulatory submissions (e.g. NDA/BLA/MAA) is preferred.

Responsibilities

• Supports management and delivery of labelling activities across assigned products/portfolio.
• Contributes to development, preparation, review, and approval of global labelling docs (TPL, CCDS, Core Patient Information) and territorial labelling (EU SmPC, USPI).
• Supports development of labelling strategy in partnership with Global Regulatory, ensuring alignment with regulatory strategy and business objectives.
• Leads labelling updates and development, evaluating data for scientific accuracy and regulatory acceptability.
• Chairs or contributes to Product Labelling Teams (PLTs) and escalates issues to the Global Labelling Committee (GLC).
• Reviews and approves promotional and non-promotional materials for CCDS alignment.

Skills

Regulatory labelling

Cross-functional collaboration

Communication skills

Presentation skills

Regulatory strategy

Education

Bachelor’s degree in Science/Medicine/Pharmacy

Advanced degree advantageous

Job description

Mylan Inc. 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. Every day, we rise to the challenge to make a difference and here’s how the Manager, Core Labeling Strategy will make an impact: 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.

Key responsibilities for this role include:

• Supports management and delivery of labelling activities across assigned products/portfolio.
• Contributes to 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.
• Supports development of labelling strategy in partnership with Global Regulatory, ensuring alignment with overall regulatory strategy and business objectives.
• May contribute 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.
• Performs other labelling-related duties as assigned.

The minimum qualifications for this role are:

• Bachelor’s degree (or equivalent) in Science, Medicine, Pharmacy, or related field with typically 3-5 years of 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.
• Highly developed interpersonal, presentation and communication skills.
• Ability to provide innovative approaches/recommendations to product labelling that meet corporate goals while maintaining compliance with relevant laws and regulations.
• The ability to influence effectively in a matrixed, cross-functional team environment.
• Position functions autonomously. Carry out responsibilities in accordance with the organization's policies and applicable laws. Responsibilities may include training employees.

Exact compensation may vary based on skills, experience, and location. The salary range for this position is $78.000.00 - $152,000.00 USD.

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. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.

Viatris est une entreprise mondiale de services de santé créée en 2020 par la combinaison de Mylan et Upjohn, une division héritée de Pfizer. En intégrant les atouts de ces deux entreprises, y compris notre main-d’œuvre mondiale d’environ 45 000 personnes, nous visons à offrir un accès accru à des médicaments abordables et de qualité pour les patients du monde entier, indépendamment de la géographie ou des circonstances. Nous croyons aux services de santé comme ils devraient l’être, permettant aux personnes du monde entier de vivre plus sainement à chaque étape de la vie. Et parce que nous croyons fermement qu’un meilleur accès aux soins conduit à une meilleure santé, nous réunissons des compétences scientifiques et logistiques d’excellence, ainsi que des expertises commerciales éprouvées pour fournir des médicaments de qualité aux patients, où et quand ils en ont besoin.