Global Labeling Strategy Lead

Viatris; Washington; On-site; USD 78,000 - 152,000; Full time

Job summary

Viatris seeks a Manager, Core Labeling Strategy to provide global regulatory labelling leadership for existing and new products. You will develop and maintain Core Labelling and support global ad promo review in line with company policies.

You will work with Regulatory, Medical, Safety, and Clinical teams to ensure accurate labeling, strategic labelling decisions, and alignment with submissions (USPI, EU SmPC).

Qualifications

• Bachelor’s degree (or equivalent) in Science, Medicine, Pharmacy, or related field with typically 3–5 years of experience, including significant labelling experience.
• 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.
• Strong interpersonal, presentation and communication skills; ability to influence in a matrixed team.

Responsibilities

• 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).
• Supports development of labelling strategy in partnership with Global Regulatory, ensuring alignment with regulatory strategy and business objectives.
• May contribute to development and maintenance of Target Product Labelling (TPL).
• Establishes cross‑functional partnerships with Regulatory Strategists, Medical, Safety, and Clinical teams.
• Leads labelling updates and development, evaluating data for accuracy and regulatory acceptability.
• Assesses deviations from Company Core Position (e.g. CCDS) and supports responses to Health Authority requests.
• Chairs or contributes to Product Labelling Teams (PLTs) and escalates to Global Labelling Committee as needed.
• Maintains awareness of competitor labelling and regulatory trends to inform strategy.
• Manages regulatory and scientific labelling issues balancing compliance with business needs.
• Contributes to interpretation of emerging regulatory guidelines.
• Represents Viatris in external forums (e.g. EMA/FDA workshops).
• Reviews and approves promotional and non‑promotional materials for CCDS alignment.
• Reviews documents (IB, protocols, CSR, PSURs, RMPs) as appropriate.
• Provides labelling expertise in cross‑functional discussions.
• Performs other labelling-related duties.

Job description

Viatris seeks a Manager, Core Labeling Strategy to provide global regulatory labelling leadership for existing and new products. You will develop and maintain Core Labelling and support global ad promo review in line with company policies.

You will work with Regulatory, Medical, Safety, and Clinical teams to ensure accurate labeling, strategic labelling decisions, and alignment with submissions (USPI, EU SmPC).