Regulatory Labeling and Promotion Manager, Atlanta, GA
Regulatory Labeling and Promotion Manager, Atlanta, GA
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$ 104800 - 137600
1 Vacancy
Job Description
Make your mark for patients
We seek a talented Regulatory Labeling and Promotion Manager who is skilled at balancing operational excellence with a proactive strategic approach to regulatory affairs. The Regulatory Labeling and Promotion Manager will play a critical role in ensuring regulatory compliance while driving continuous improvement within the organization.
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 youll 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 youll 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.
Interested For this role were looking for:
Minimum Qualifications
- Bachelors 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
This positions anticipated salary range is $104800$137600 per year. Actual pay will vary based on factors such as internal equity geographic location skills and experience.
Are you ready to go beyond to create value and make your mark for patients If this sounds like you then we would love to hear from you!
About us
UCB is a global biopharmaceutical company focusing on neurology and immunology. We are around 8500 people in all four corners of the globe inspired by patients and driven by science.
Why work with us
At UCB we dont just complete tasks we create value. We arent 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 thats 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.
UCB is an equal opportunity 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.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on 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.
Required Experience:
Manager
Employment Type
Full-Time
