Senior Manager, Core Labeling Strategy

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 lifes 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 heres how the Senior 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:

• 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.

• Performs other labelling-related duties as assigned.

The minimum qualifications for this role are:

• Bachelors degree (or equivalent) in Science Medicine Pharmacy or related field with typically 710 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. The position may directly supervise employees. Carry out supervisory responsibilities in accordance with the organizations policies and applicable laws. Responsibilities may include interviewing hiring and training employees; planning assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Exact compensation may vary based on skills experience and location. The salary range for this position is $95000.00 - $193000.00 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.