Make your mark for patients

About the role:

 

Regulatory Labeling, Advertising and Promotion Lead (Associate Director)

 

We’re looking for a Regulatory Labeling, Advertising and Promotion Lead that works with integrity, has strategic orientation, is flexible/adaptable to change and has excellent communication skills to join our Regulatory Labeling, Advertising and Promotion team in Atlanta, GA.

 

Primary Purpose / Regulatory Responsibilities:

This individual will provide oversight of the US Regulatory Labeling, Advertising and Promotion team and manage a team of direct reports. In collaboration with Regulatory Labeling, will serve as an Advertising and Promotion Expert representative on project teams and committees where decisions and outcomes potentially impact all products.   

 

What you’ll do:

 

Labeling Responsibilities

US Regulatory expert in US regulation of advertising and promotion and industry standards for labeling and communicate requirements to others as needed.Oversight of the development and maintenance of procedures for the regulatory aspects of labeling preparation, review, approval and submission.Direct the labeling control process for tracking, implementation and regulatory submission of changes to existing labeling.  Interface with the Head of Global Labeling Function to ensure consistency of labeling processes and local compliance with CCDS.Serve as US Regulatory labeling expert in internal and external audits.Oversight of CAPA resolution.Serve as US Regulatory labeling expert in project teams for activities impacting labeling across multiple products.Provide oversight of FDA establishment registration, drug product listing, and import procedures in collaboration with Regulatory Labeling and Advertising and Promotion Manager, US.Provide back up support to Regulatory Labeling, Advertising and Promotion Scientists and Managers as needed based on workload.

Promotional Material/External Communications Responsibilities

US Regulatory expert regarding requirements for US regulation of drug marketing and advertising and competitive landscape.  Communicate FDA requirements and trends to other UCB departments involved in the preparation or review of external communication materials.Provides guidance to Regulatory Labeling, Advertising and Promotion Scientists as needed during negotiations in cross functional teams. Serve as US Regulatory lead in cross functional teams where promotional or scientific communication policies/procedures are being developed or revised.Serve as back up to Regulatory Labeling, Advertising and Promotion Scientists, US as needed in cross functional promotion committee meetings.

Management responsibilities:

Provide leadership and guidance to Regulatory Labeling, Advertising and Promotion Scientists and Managers, US.Interact with senior management, external departments and regulatory authorities as needed.Participate in forecasting and planning activities for US Regulatory Labeling resources.

 

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

 

Minimum Qualifications:

Bachelors Degree with 7+ years of relevant experience in the pharmaceutical industry with 5+ years in Regulatory Affairs and specific experience in US Advertising and Promotion/Labeling experience.

 

 

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 8,500 people in all four corners of the globe, inspired by patients and driven by science.

Why work for us?
At UCB, we don’t just complete tasks, we create value. We aren’t 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 equitable opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s 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.

Learn more about sustainability at UCB and how it is integrated into our business approach.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/colour/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.