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US Labeling

4 months ago

Atlanta, Georgia, United States UCB Full time

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 followingeducation, experience,andskills :

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.

Internal applicants should be in their current job for at least 12 months, must meet performance standards and are not on formal corrective/disciplinary process (PIP), warning, final warning, or compliance warning letters within the last 12 months. Please inform your Manager or your Talent Partner before applying to any internal job opportunities.

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/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.

Requisition ID: 86051

Recruiter: John Gasbarre

Hiring Manager: Leo Anthony DiNapoli

Talent Partner: Bianca Hinshaw