Senior Manager, Global Regulatory Labeling

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Moderna offers an opportunity to be part of a pioneering team that is revolutionizing medicine through mRNA technology. The role focuses on advancing global labeling for an innovative biotech pipeline in Warsaw, Poland, and involves expanding into Middle Eastern and Asia Pacific markets.

About the Role

• Drive the preparation and maintenance of product labeling in compliance with global regulatory requirements.
• Oversee the submission, tracking, and approval of labeling content across all regulatory stages.
• Act as the key point of contact for cross‑functional labeling initiatives.
• Develop new prescribing information aligned with regional regulatory expectations.
• Ensure consistency and compliance of labeling processes through alignment with cross‑functional project teams.
• Monitor evolving global labeling trends and influence industry standards.

Your Responsibilities

• Apply deep understanding of international labeling regulations and standards, advising internal stakeholders to maintain compliance across labeling deliverables.
• Contribute to the operational control and tracking of labeling changes from development through submission and approval stages.
• Collaborate with Regulatory Strategy Leads to craft labeling text aligned with Core Company Data Sheets (CCDS) and product strategy.
• Manage the submission of labeling components and supporting documents to global health authorities in accordance with regulatory frameworks.
• Serve as the labeling representative in Global Regulatory Affairs Sub Teams (GRSTs) to support submission activities.
• Support labeling‑related change controls by gathering documentation and maintaining compliance within the electronic document management system.
• Oversee the end‑to‑end labeling lifecycle, ensuring accuracy, timeliness, and regulatory readiness.

Mindsets & Skills

• Strong understanding of electronic systems and document management platforms to drive regulatory labeling processes.
• Ability to operate with speed, precision, and foresight to meet labeling timelines.
• Advanced degree preferred; at least 5–8 years of experience in the pharmaceutical industry, with 5+ years in Regulatory Affairs and labeling.
• Experience with major applications (NDA/BLA/MAA/JNDA, etc.) and labeling (CCDS, US, EU).
• Excellent leadership, communication, and collaboration skills.
• Proven medical/technical writing ability.
• Integrity, result orientation, strategic vision, and adaptability.

Benefits

• Quality healthcare and insurance benefits.
• Lifestyle Spending Accounts.
• Free premium access to fitness, nutrition, and mindfulness classes.
• Family planning and adoption benefits.
• Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and global recharge days.
• Savings and investment plans.
• Location‑specific perks and extras.

Moderna is a smoke‑free, alcohol‑free, and drug‑free work environment. We are committed to creating an inclusive workplace that values diverse experiences and background. We provide reasonable accommodation for qualified applicants with disabilities; please contact our Accommodations and Adjustments team at leavesandaccommodations@modernatx.com.

EEO Statement

Moderna is committed to equal opportunity in employment and non‑discrimination for all employees and qualified applicants without regard to a persons race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. We offer reasonable accommodation or adjustments to qualified job applicants with disabilities.