Regulatory Labelling Ad/Promo Manager

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Date: Nov 13, 2018

Location: Atlanta, Georgia, US

Act as regulatory approver of all advertising and promotional materials and take an active role in submission of these materials to the FDA. As the regulatory representative to the cross functional team creating the advertising and promotional materials, bring product knowledge, information on previous submissions, FDA enforcement trends, and the competitive landscape to all discussions.

Leads development of new labeling content in collaboration with cross functional project team.  Manages the creation and maintenance of all US product labeling components using the established labeling and artwork procedures in collaboration with the Regulatory Labeling, Advertising and Promotion Scientists.  Compilation of labeling documents for all submissions which include labeling information.  Responsible for drug listing for product manufactured by UCB for distribution within the US. 

 

Promotional Material/External Communications Responsibilities

  • Develop and maintain current knowledge of requirements for US regulation of drug marketing and advertising and competitive landscape.  Communicate FDA requirements to other UCB departments involved in the preparation or review of external communication materials.
  • Collaborates with co-creation partners in the development of new promotional initiatives/programs and reviews supporting materials ensuring compliance and consistency with internal policies, Code of Federal Regulations (CFR), FDA guidance documents, PhRMA Guiding Principles, and the Federal Food, Drug, and Cosmetic Act.  Negotiates promotional regulatory position within cross-functional team.
  • Works on complex OPDP submissions in collaboration with Regulatory Labeling, Advertising and Promotion Manager, US
  • Participates in and/or directs the regulatory review of non-promotional scientific information, and external communication materials, including media information and provides proactive feedback.
  • 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.
  • Direct the labeling control process for tracking, implementation and regulatory submission of changes to existing labeling.
  • Interface with the Global Labeling Function (GLF) to ensure consistency of labeling processes and local compliance with CCDS.
  • Compilation of Labeling Review Committee (LRC) packages for all US labeling components.
  • Manage LRC and GLF reviews and approvals.
  • Manage artwork revisions to US labeling components using the established artwork processes
  • Compilation of labeling documents required for all FDA submissions which include labeling information.
  • Maintenance of drug product listings.
  • Manage generation of SPL for inclusion in labeling submissions and drug product listings.
  • Collaborate with Supply Chain to coordinate implementation strategy for new labeling artwork components.

 

Minimal Requirements: 

  • Bachelor Degree Required
  • At least 3 years of relevant experience in the pharmaceutical industry with preferably 2 years in Regulatory Affairs and specific experience in US advertising and promotion material review and approval, and labeling
  • Basic knowledge of US labeling and promotion regulations and guidance.
  • Knowledge of science and data of assigned products and how that translates into labeling language.
  • Knowledge of competitive landscape and how other companies are dealing with similar issues in labeling and promotion.
  • Experience of product launch preferred

 

UCB is a global biopharmaceutical company. We focus on discovering and developing innovative medicines and lateral solutions that can transform the everyday lives of people living with severe disease.

With more than 7500 people in approximately 40 countries, UCB offers an exciting working environment where initiative can flourish and those with a ‘can-do’ attitude can thrive.  Thinking holistically, working together, championing change, delivering impactful results…these are some of the key competencies we are constantly developing, and looking for, at UCB.

UCB and its subsidiaries encourage diversity in the workplace; we are an Equal Opportunity Employer.  Minority/Female/Disability/Veteran


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