Senior Manager

Description:

Moderna is seeking a Senior Manager, Labeling Operations, Artwork to join their Oxford office (Harwell) and lead end-to-end labeling operations for their global pipeline of mRNA medicines. This role is critical for ensuring the generation, revision, and submission of prescribing information and regulatory artwork, particularly for the Middle East and Asia Pacific markets. The position serves as a subject matter expert within Global Regulatory Affairs, interfacing cross-functionally with regulatory strategists, project teams, and global health authorities to ensure compliance, accuracy, and timely delivery of labeling materials.

The role is ideal for a regulatory labeling professional looking to influence global labeling strategies while contributing to Moderna’s mission of advancing mRNA medicine.

Key Responsibilities:

• Generate, revise, and submit prescribing information and regulatory artwork for global submissions, with a focus on Middle East and Asia Pacific markets.

• Provide expertise in regulatory labeling operations across the product lifecycle, ensuring regional compliance and timely execution.

• Collaborate with Regulatory Strategy Leads and project teams to align content, requirements, and timelines.

• Act as the regulatory labeling representative on Global Regulatory Affairs Sub Teams (GRSTs).

• Support labeling control processes, including change implementation and tracking via electronic document management systems.

• Review and approve regulatory artwork content and documentation.

• Maintain awareness of evolving regulatory and industry labeling standards, influencing internal best practices.

Requirements / About You:

• Bachelor’s degree required; advanced degree preferred.

• 5–8 years of relevant pharmaceutical industry experience, with 5+ years in Regulatory Affairs and labeling.

• Experience delivering labeling for at least one major submission (NDA/BLA/MAA/JNDA).

• Hands-on knowledge of science and product data as it applies to labeling language.

• Excellent leadership, communication, collaboration, and medical/technical writing skills.

• Familiarity with CCDS, US, EU labeling, especially in infectious diseases or vaccines, is desirable.

• Strong analytical thinking, problem-solving, and ability to drive consensus.

• Ability to adapt, work in cross-functional teams, and align strategic objectives with daily work.

Benefits:

• Quality healthcare and insurance benefits.

• Lifestyle Spending Accounts for wellbeing initiatives.

• Access to fitness, nutrition, and mindfulness programs.

• Family planning, adoption benefits, and generous paid time off (vacation, bank holidays, volunteer days, global recharge days, year-end shutdown).

• Savings and investment plans.

• 70/30 in-office work model to foster collaboration and innovation.