???? Location: Hybrid (US Headquarters in Atlanta, GA, Raleigh, NC, or Cambridge, MA)
???? Job Type: Full-Time (Not Remote)
???? Compensation Range:
- Atlanta, GA & Raleigh, NC: $86,400 - $137,600/year
- Cambridge, MA: $97,600 - $153,300/year
At UCB, we go beyond…
Are you passionate about ensuring accurate and compliant labeling for life-changing pharmaceutical products? Do you have the drive to lead and innovate within the dynamic world of Regulatory Affairs? At UCB, we believe in making our mark for patients, and we're looking for an exceptional US Labeling Scientist to help us create value and continue transforming the industry.
What You'll Do
As a US Labeling Scientist, you'll lead the development and maintenance of all US product labeling components in collaboration with key stakeholders across the company. You will play a critical role in ensuring that all labeling content is consistent, accurate, and fully aligned with US regulations and industry standards. Key responsibilities include:
- Labeling Development & Maintenance: Oversee the creation, revision, and control of all labeling materials to ensure compliance with US regulations.
- Collaboration: Work with cross-functional teams including Regulatory Leads, Artwork Teams, and Advertising/Promotion Scientists to maintain high-quality product labeling.
- Regulatory Submissions: Compile labeling documents for all FDA submissions, coordinate artwork revisions, and manage submission timelines.
- Drug Listing & Registration: Maintain drug product listings and manage establishment registrations for UCB’s products distributed in the US.
- Process Improvement: Work to optimize and enhance the efficiency of labeling processes while ensuring compliance with evolving regulations.
What We're Looking For
- Education: Bachelor’s degree required; Master’s degree preferred.
- Experience: At least 2 years of experience in the pharmaceutical industry, with 1+ years in US Labeling or Regulatory Affairs.
- Technical Knowledge: Strong understanding of US labeling regulations and industry standards.
- Skills: Proficiency in managing large datasets and documentation related to labeling, artwork, and submissions.
- Industry Awareness: Knowledge of product launch processes and the competitive landscape.
- Communication: Excellent written and verbal communication skills to collaborate with internal teams and stakeholders.
Required Competencies
- Integrity: A commitment to high standards of work and ethics.
- Results-Oriented: Drive to meet and exceed excellence in all tasks.
- Strategic Vision: Ability to connect long-term strategies with day-to-day work.
- Communication Skills: Ability to clearly convey information to diverse audiences, including stakeholders in Supply Chain and FDA submissions.
- Adaptability: Thrive in dynamic environments and adjust to new demands quickly.
- Teamwork: Cultivate strong relationships and cooperate across teams.
Why UCB?
- Global Impact: Work with a leading biopharmaceutical company at the forefront of neurology and immunology.
- Patient-Focused: Help shape life-saving treatments that have a direct impact on patient lives.
- Inclusive Culture: Join a supportive and inclusive work environment where diverse perspectives are valued.
- Career Growth: Be empowered to create your own career path and grow within UCB’s dynamic ecosystem.
- Caring Environment: We prioritize the well-being of our employees, patients, and the planet.
Ready to Make Your Mark?
If you're driven by the chance to contribute to a better future for patients, we'd love to hear from you! Join UCB and be part of our human-focused journey toward innovation and patient care.
