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Global Regulatory Labeling, Promotion and Advertising U.S. Lead
Global Regulatory Labeling, Promotion and Advertising U.S. LeadUCB • Atlanta, Georgia, United States
Global Regulatory Labeling, Promotion and Advertising U.S. Lead

Global Regulatory Labeling, Promotion and Advertising U.S. Lead

UCB • Atlanta, Georgia, United States
[job_card.30_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

Make your mark for patients

We are looking for a Global Regulatory Labeling, Promotion and Advertising U.S. Lead who is motivating, collaborating, and inspiring to join us in our Global Labeling, Promotion and Advertising team, based in our U.S. Headquarters in Atlanta, GA.

About the role

The Global Regulatory Labeling, Promotion, and Advertising US Lead is responsible for ensuring compliance with the US regulatory requirements for labeling, promotional, and advertising materials. This role oversees the development, implementation, and maintenance of global labeling strategies for the US region, as well as the regulatory review of promotional and advertising content. The Lead provides strategic leadership to cross-functional teams, ensuring alignment with business objectives while maintaining compliance with evolving regulatory frameworks.

Who you’ll work with

You will lead the development and execution of global labeling strategies, ensuring consistency and compliance with US markets. Additionally, you will be accountable for the Target Core Labeling Profile (TCLP) process, Company Core Data Sheet (CCDS) process, Local Labeling Committees (LLC), and promotional Review Committees (RC).

What you’ll do

The Lead will also have responsibility for a brand / asset, ensuring strategic alignment and execution of labeling and promotional / advertising initiatives.

Target Core Labeling Profile (TCLP) :

  • Contruibute to the development and maintainance of the Target Core Labeling Profile (TCLP) to drive the US strategy and ensure differentiation of products for commercial success.
  • Provide regulatory US expertise to internal teams to ensure proper utilization of TCLP in development and commercialization strategies.

Local Labeling Committee Responsibilities :

  • Oversee the governance and execution of the US Labeling Committee, ensuring alignment with global and regional regulatory requirements.
  • Facilitate discussions and decision-making US label changes in compliance with CCDS.
  • Collaborate with regional regulatory leads to ensure timely implementation of local label updates.
  • Provide regulatory oversight to ensure consistency and risk mitigation in US labeling decisions.

    • Promotional Review Committee Responsibilities :

  • Provides regulatory expertise for creation and review of promotional material
  • Collaborate with Medical, Legal, and Commercial teams to review and approve promotional content.
  • Provide regulatory guidance on claims, risk disclosures, and appropriate messaging in promotional materials.
  • Ensure timely review and feedback on promotional assets to support commercial timelines while maintaining compliance to global and regional regulatory requirements.
  • Monitor evolving advertising regulations and industry standards to adapt review processes as needed.

    • Interested? For this role we’re looking for the following

    Minimum requirements

  • 12 years of relevant experience in the pharmaceutical industry with 10 years directly in Regulatory Affairs.
  • 5 years of experience and knowledge in US labeling and Promotion / Advertising regulations and guidance.
  • 5 years of experience and knowledge of science and data of assigned products and how that translates into labeling language.
  • Demonstrated experience of product launch.

    • Preferred qualifications

  • Regulatory Expertise : In-depth knowledge of US regulatory requirements related to labeling, promotion, and advertising.
  • Strategic Thinking : Ability to develop and implement long-term regulatory strategies that align with business objectives.
  • Leadership & Team Development : Proven experience in managing and mentoring cross functional teams, fostering a culture of collaboration and high performance.
  • Cross-functional Communication : Strong ability to collaborate with diverse teams, influence stakeholders, and provide regulatory guidance effectively.
  • Analytical & Problem-Solving Skills : Ability to assess complex regulatory challenges and develop pragmatic solutions.
  • Project Management : Strong organizational skills to manage multiple projects simultaneously, ensuring timely execution and regulatory compliance.
  • Attention to Detail : Ensuring accuracy and consistency in regulatory documentation, submissions, and labeling content.
  • Adaptability & Continuous Learning : Ability to navigate changing regulatory environments and implement necessary process improvements proactively.

    • This position's reasonably anticipated salary range is $148,000 - $241,500 per year. The actual salary offered will take into account internal equity and also may vary depending on the candidate’s geographic region, job-related knowledge, skills, and experience, among other factors.

    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!

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