Regulatory Labeling, Advertising and Promotion Scientist

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Date: Jul 14, 2019

Location: Atlanta, US

We all share one big ambition. What’s yours?

 

Everyone who works at UCB holds the same ambition – to transform the lives of people living with severe diseases.  Of course we have other associated ambitions too - including a desire to support each other in attaining all of our own personal and professional goals. That’s why we ensure every UCB colleague has the tools and environment to engage effectively in the work we do. Wherever in the world we’re based, and whatever role we play, we believe each of us can have an impact across our organization.

To help us meet our ambitions and provide the best solutions to patients, UCB is currently seeking a talented individual as a Regulatory Labeling, Advertising and Promotion Scientist, US based at our US Headquarters in suburban Atlanta, Georgia. Relocation would be provided for the right candidate. 

 

Nature and Scope:

As an expert in US regulations related to advertising and promotional materials for pharmaceutical products, guide the development of materials with cross-functional partners. Act as regulatory approver of advertising and promotional materials and take an active role in submission of these materials to the FDA. As the regulatory representative to the team creating the advertising and promotional materials, bring product knowledge, information on previous submissions, and relevant information about the competitive landscape to all discussions.

 

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.

 

Management responsibilities

 

  • Provide leadership and guidance to labeling/promotion managers.
  • Interact with senior management, external departments and regulatory authorities as needed.
  • Participate in forecasting and planning activities for resources for the US Regulatory Affairs group for the future needs for Regulatory Affairs.

 

Education and skills

 

  • Bachelor's Degree 
  • At least 6 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
  • Extended 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 with severe diseases of the immune system – or the central nervous system.

 

With more than 8500 people in approximately 40 countries, UCB offers an exciting working environment where initiative can flourish and those with a ‘can-do’ attitude can thrive.  Scientific excellence, innovation, co-creation, lateral thinking, reinventing the way we do things…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


Nearest Major Market: Atlanta

Job Segment: Law, Scientific, Regulatory Affairs, Advertising, Scientist, Legal, Engineering, Marketing, Science

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