Make your mark for patients.

We're here because we want to build the future and transform patients' lives for the better. To achieve that, we need the brightest minds and biggest hearts. That's why our Talent Acquisition Team looks for passionate people inside and outside the company. Are you interested in an internal move that will allow you to explore how much more you can do to make a difference for people living with severe disease?

To strengthen our Product Information - Regulatory Affairs group, based in our Smyrna, GA offices, we are looking for a talented individual to fill the position of: Regulatory Labeling, Advertising and Promotion Scientist.

The Regulatory Labeling, Advertising, and Promotion Scientist act as a regulatory approver of all advertising and promotional materials and take an active role in the submission of these materials to the FDA.

You like to work in an environment where you can:

• Operate as the regulatory representative to the cross-functional team creating the advertising and promotional materials, bringing product knowledge, information on previous submissions, FDA enforcement trends, and the competitive landscape to all discussions.
• Lead development of new labeling content in collaboration with cross-functional project team.
• Manage the creation and maintenance of all US product labeling components using the established labeling and artwork procedures in collaboration with the Regulatory Labeling, Advertising, and Promotion Scientist Lead.
• Compile labeling documents for all submissions which include labeling information.
• Take charge of drug listing for products manufactured by UCB for distribution within the US.
• Develop and maintain current knowledge of requirements for US regulation of drug marketing and advertising and competitive landscape.
  • Communicate FDA requirements to other UCB departments involved in the preparation or review of external communication materials.
• Collaborate with co-creation partners in the development of new promotional initiatives/programs and review supporting materials ensuring compliance and consistency with internal policies, Code of Federal Regulations (CFR), FDA guidance documents, PhRMA Guiding Principles, and the Federal Food, Drug, and Cosmetic Act.
  • Negotiates promotional regulatory position within a cross-functional team.
• Works on complex OPDP submissions in collaboration with Regulatory Labeling, Advertising and Promotion Manager, US.
• Participate in and/or directs the regulatory review of non-promotional scientific information, and external communication materials, including media information and provide proactive feedback.

You will contribute by:

• Developing and maintaining current knowledge of US regulation of labeling and industry standards for labeling and communicate requirements to other departments in a timely manner.
• Directing the labeling control process for tracking, implementation, and regulatory submission of changes to existing labeling.
• Interfacing with the Global Labeling Function (GLF) to ensure consistency of labeling processes and local compliance with CCDS.
• Compiling Labeling Review Committee (LRC) packages for all US labeling components.
• Managing LRC and GLF reviews and approvals.
• Managing artwork revisions to US labeling components using the established artwork processes.
• Compiling labeling documents required for all FDA submissions which include labeling information.
• Maintaining drug product listings.
• Managing generation of SPL for inclusion in labeling submissions and drug product listings.
• Collaborating with Supply Chain to coordinate implementation strategy for new labeling artwork components.

Interested? For this position, you'll need the following education, experience, and skills:

Minimum Qualifications:

• BSc with 3+ years of relevant experience in the pharmaceutical industry.
  • 2+ years in Regulatory Affairs and specific experience in US advertising and promotion material review, approval, and labeling.
• Demonstrated knowledge of US labeling and promotion regulations and guidance.
• Thorough knowledge of science and data of assigned products and how that translates into labeling language.
• Proven track record of competitive landscape and how other companies are dealing with similar issues in labeling and promotion.
• Demonstrated experience of product launch within previous organizations.

About us.

At UCB, we come together every day to work, laser-focused, on a simple question: How will this create value for people living with severe diseases? By putting patients at the heart of everything we do, our approach - from discovery to development to delivery - is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,600 employees and worldwide operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases. We are looking for people with passion and empathy who develop a real understanding of patient's needs and can deliver thoughtful solutions to decisionmakers across the heath care ecosystem.

Curious to know more? Please visit our website .

The Company is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.

Where permitted, applicants for employment in the United States must either have received or been willing to receive a full COVID-19 vaccination by the date of hire; or, alternatively, agree to be subject to weekly COVID-19 testing, subject to religious and medical exemptions and in accordance with applicable law.