UCB
Regulatory Labeling and Promotion Manager, Atlanta, GA
UCB, Atlanta, Georgia, United States, 30383
Overview
Regulatory Labeling and Promotion Manager, Atlanta, GA. Based in our Atlanta office. The role leads regulatory labeling activities to ensure compliance and supports continuous improvement within 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 and 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
Bachelor’s degree 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 Compensation
The 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. About Us
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science. Why work with us?
At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential. Equal Opportunity
UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable federal, state, or local law. UCB invites you to voluntarily self-identify during the application process. Provision of self-identification information is entirely voluntary and a decision to provide or not provide such information will not have any effect on your application for employment, your employment with UCB, or otherwise subject you to any adverse treatment. Any information you provide will be considered confidential and will be kept separate from your application and/or personnel file and will only be used in accordance with applicable laws, orders, and regulations. Reasonable Accommodation
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on US-Reasonable_Accommodation@ucb.com for application to US based roles. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
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Regulatory Labeling and Promotion Manager, Atlanta, GA. Based in our Atlanta office. The role leads regulatory labeling activities to ensure compliance and supports continuous improvement within 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 and 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
Bachelor’s degree 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 Compensation
The 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. About Us
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science. Why work with us?
At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential. Equal Opportunity
UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable federal, state, or local law. UCB invites you to voluntarily self-identify during the application process. Provision of self-identification information is entirely voluntary and a decision to provide or not provide such information will not have any effect on your application for employment, your employment with UCB, or otherwise subject you to any adverse treatment. Any information you provide will be considered confidential and will be kept separate from your application and/or personnel file and will only be used in accordance with applicable laws, orders, and regulations. Reasonable Accommodation
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on US-Reasonable_Accommodation@ucb.com for application to US based roles. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
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