UCB
Regulatory Labeling and Promotion Manager
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This position is based in our Atlanta, GA office.
About the role The Regulatory Labeling and Promotion Manager leads maintenance of FDA product drug listings and establishment registrations, supports development and maintenance of product labeling and artwork to ensure compliance with FDA requirements, and manages development of labeling documents for FDA submissions. This role requires both operational focus and a strategic mindset to anticipate regulatory changes, optimize labeling processes, and contribute to the success of the regulatory function.
What you’ll do
Regulatory Compliance & Submissions
Lead and maintain drug product listings, establishment registrations, and Structured Product Labeling (SPL) submissions to ensure full FDA compliance.
Compile and review labeling documentation for FDA and OPDP submissions.
Review shipper and pallet labels for imported products, ensuring FDA and Customs compliance.
Labeling and Promotion Review Support
Provide support for product promotion material reviews as well as support for OPDP promotional material submissions.
Support Labeling Review Committee (LRC) processes, including labeling revisions and accuracy in regulatory systems.
Manage revisions to labeling artwork ensuring compliance with regulatory requirements.
Cross-Functional Collaboration & Strategy
Partner with Regulatory partners, Packaging and Artwork team, and business teams to align labeling strategies.
Identify process improvements and efficiency opportunities in labeling and submission workflows.
Anticipate and prepare for regulatory changes by monitoring FDA regulations, assessing risks, and recommending proactive compliance solutions.
Maintain up-to-date knowledge of US labeling regulations and industry standards.
Who you’ll work with You will collaborate closely with the Regulatory Labeling and Promotion Senior Manager, cross-functional partners, packaging and artwork teams, and stakeholders across Regulatory Affairs to ensure compliance and business alignment.
Minimum Qualifications
Minimum 2 years of US Regulatory Affairs US labeling experience
Basic knowledge of US labeling and promotion regulations and guidance
Preferred Qualifications
Experience supporting product launches
Salary This position's anticipated salary range is $104,800–$137,600 per year. Actual pay will vary based on factors such as internal equity, geographic location, skills, and experience.
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This position is based in our Atlanta, GA office.
About the role The Regulatory Labeling and Promotion Manager leads maintenance of FDA product drug listings and establishment registrations, supports development and maintenance of product labeling and artwork to ensure compliance with FDA requirements, and manages development of labeling documents for FDA submissions. This role requires both operational focus and a strategic mindset to anticipate regulatory changes, optimize labeling processes, and contribute to the success of the regulatory function.
What you’ll do
Regulatory Compliance & Submissions
Lead and maintain drug product listings, establishment registrations, and Structured Product Labeling (SPL) submissions to ensure full FDA compliance.
Compile and review labeling documentation for FDA and OPDP submissions.
Review shipper and pallet labels for imported products, ensuring FDA and Customs compliance.
Labeling and Promotion Review Support
Provide support for product promotion material reviews as well as support for OPDP promotional material submissions.
Support Labeling Review Committee (LRC) processes, including labeling revisions and accuracy in regulatory systems.
Manage revisions to labeling artwork ensuring compliance with regulatory requirements.
Cross-Functional Collaboration & Strategy
Partner with Regulatory partners, Packaging and Artwork team, and business teams to align labeling strategies.
Identify process improvements and efficiency opportunities in labeling and submission workflows.
Anticipate and prepare for regulatory changes by monitoring FDA regulations, assessing risks, and recommending proactive compliance solutions.
Maintain up-to-date knowledge of US labeling regulations and industry standards.
Who you’ll work with You will collaborate closely with the Regulatory Labeling and Promotion Senior Manager, cross-functional partners, packaging and artwork teams, and stakeholders across Regulatory Affairs to ensure compliance and business alignment.
Minimum Qualifications
Minimum 2 years of US Regulatory Affairs US labeling experience
Basic knowledge of US labeling and promotion regulations and guidance
Preferred Qualifications
Experience supporting product launches
Salary This position's anticipated salary range is $104,800–$137,600 per year. Actual pay will vary based on factors such as internal equity, geographic location, skills, and experience.
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