Make your mark for patients.

We're here because we want to build the future and transform patients' lives for the better.

At UCB, our people are our experiences and achievements, our passion and drive. That's why we're looking for talented individuals with diverse backgrounds and experiences - not just the best and brightest, but those who care about making a meaningful difference in the lives of patients. We promote an environment of diversity, openness, and respect where people can make valuable contributions.

An exciting journey lies ahead. Will you join us in pushing the boundaries of what's possible?

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 Operations Manager.

The Regulatory Labeling, Advertising and Promotion Operations Manager will be responsible for the submissions / maintenance of FDA Drug Listings and establishment registrations manage OPDP submissions for UCB products marketed in the US.

You like to work in an environment where you can:

• Maintain drug product listings and establishment registrations including facilitate resolution of import related issues
• Manage the creation and maintenance of US product labeling components using the established labeling and artwork procedures in collaboration with the Regulatory Labeling, Advertising and Promotion Scientists.
• Compile labeling documents for all FDA submissions which include labeling information.
• Maintain drug product listings and establishment registrations.
• Develop and maintain current knowledge of US regulation of labeling and industry standards for labeling and communicate requirements to other departments in a timely manner.
• Compile Labeling Review Committee (LRC) packages for all US labeling components.
• Manage LRC reviews and approvals in collaboration with Regulatory Labeling, Advertising and Promotion Scientists.

You will contribute by:

• Managing artwork revisions to US labeling components using the established artwork processes.
• Compiling labeling documents required for all FDA submissions which include labeling information.
• Managing generation of SPL for inclusion in labeling submissions and drug product listings.
• Amassing documentation for OPDP submission and coordinate submission with the Regulatory Labeling, Advertising and Promotion Scientists and Review Services.
• Interfacing with external contractor to manage OPDP interactions.
• Archiving of labeling documentation and artwork.
• NDC number assignment and management of NDC database.
• 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 pharmaceutical FDA Establishment Registration and Drug Listing, as well as, end-to-end labeling process experience.
• Demonstrated competencies in the areas of:
  • Integrity: overriding commitment to integrity and high standards in self and others.
  • Achievement or Result Orientation: a concern for working well or for surpassing a standard of excellence.
  • Strategic orientation: ability to link visions and daily work.
  • Communication: ability to effectively explain, describe or convey information to a variety of audiences.
    • Effectively communicates strategies to Supply Chain regarding implementation of new labeling revisions into product packaging. Also communicates effectively with Review Services in coordinating OPDP submissions.
  • Flexibility/ adaptability: ability to adapt to and work effectively within a variety of situations and with various individuals or groups.
  • Relationship building, teamwork and cooperation - builds or maintains friendly relationship with people and demonstrates desire to work.
  • Analytical Thinking: understand a situation by breaking it apart into small pieces or tracing the implications of a situation in a step-by-step way.
    • Systematically organizing the parts of a problem.

About us.

UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 7,600 people in all four corners of the globe, inspired by patients and driven by science.

At UCB, everything we do start with a simple question: "How will this create value for people living with severe disease?". We are on a journey to become the patient-preferred biopharma leader by delivering medicines and solutions that improve lives. We want to ensure the creation of patient value, now and into the future, while contributing to a society where a population of 8 billion people and more should be able to live a good life within limited resources of one planet.

Curious to know more? Please visit our website .

Where permitted, applicants for employment in the United States must have received or be 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.

UCB 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 protect by law.