Global Regulatory Labeling, Promotion and Advertising U.S. Lead
Global Regulatory Labeling, Promotion and Advertising U.S. Lead
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$ 148000 - 241500
1 Vacancy
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 youll 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 youll 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 were 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 positions reasonably anticipated salary range is $148000 - $241500 per year. The actual salary offered will take into account internal equity and also may vary depending on the candidates 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!
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 employer. All 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:
Exec
Employment Type
Full-Time
