Manager, Core Labeling Strategy
$78,000–$152,000 year
On-site · Washington, District of Columbia, United States
Job Summary
Manager, Core Labeling Strategy at Viatris leads global regulatory labelling activities, developing and maintaining Core Labelling (including CCDS and Core Patient Information) and supporting global Ad Promo and Medical/Commercial material review per SOPs and regulatory requirements. Responsible for contributing to Target Product Labelling, competitive labelling analysis, and regulatory precedent to support submissions (e.g., USPI, EU SmPC), and for leading cross-functional labelling efforts, including coordination with Regulatory, Medical, Safety and Clinical teams, Product Labelling Teams, and the Global Labelling Committee. Requires ensuring scientific accuracy and regulatory acceptability of labelling, guidance on label strategy across product lifecycle, and review of promotional/non-promotional materials for CCDS alignment. Minimum qualifications include a Bachelor’s degree in science/related field with 3-5 years’ labelling experience; experience with CCDS and major market labelling; familiarity with regulatory submissions; advanced degrees are a plus; strong communication and cross-functional collaboration skills. Salary range $78,000-$152,000 USD; Equal Opportunity Employer.
Required Qualifications
- 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
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.