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Head Global Labelling, Promotion

4 months ago

Atlanta, Georgia, United States UCB Full time

Make your mark for patients

We are looking for a Head of Global Labelling, Promotion & Advertisement to join us in our Global Regulatory Affairs team, based in either our Brussels, Belgium or Atlanta, Georgia (U.S.) offices.

About the role

The Head of Global Labelling & Promotion is a member of the Global Regulatory Affairs Leadership Team (GRA-LT) and provides senior leadership, mentorship, and oversight of the global and regional labelling teams (or labelling community). Accountable for global and regionally specific labelling & advertisement and promotional training pertaining to GRA's mandate.

Who you'll work with

You will report into the Global Head of Regulatory Affairs.

What you'll do

  • Responsible for providing regulatory leadership for the Labelling community by ensuring partnership between Global and Regional Labelling teams and cross- functional stakeholders.
  • Recruit, develop, and retain highly talented and skilled Labelling leads and scientists.
  • Epitomize and drive a culture of accountability and excellence, motivating employees to perform at their highest ability.
  • Active and contributing member of the GRA-LT and Secretary of the GLC.
  • Accountable for creation and maintenance of Target Core Labelling Profile (TCLP), CCDS, Prescribing Information (PI), Patient Information Leaflet (PIL or med guide), and Instructions for Use (IFUs).
  • Fosters an organizational culture that "labelling aids in driving development."
  • Oversees delivery of differentiated assets via Target Core Label Profile (TCLP) and CCDS.
  • Oversees that TCLP and CCDS process leads to well-crafted and competitive regional labels.
  • Oversees strategic and compliant lifecycle maintenance of labelling activities.
  • Is accountable for the process of Regulatory review of Promotional & Non-Promotional Materials.
  • Ensures appropriate alignment in review of promotional materials or scientific communications at global level.
  • Accountable for all general Labelling training, responsible for creating and maintaining specific training for Labelling Leads and create consistency by ensuring best practices and learnings are shared across therapeutic areas and/or products.

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

  • Bachelor's degree required, master's preferred.
  • Significant pharmaceutical industry experience. This is inclusive of several years of labelling experience or a combination of regulatory affairs and labelling and/or related experience.
  • Global labelling experience for core countries: (US & EU - required; and JP and CN preferred), with a proven track record of approved labels with business-driven differentiated profile.
  • Thorough understanding of global drug development processes that connect with global labelling regulatory requirements and processes.
  • Has developed a strategic network in the external labeling community.
  • Up to date knowledge of the global labelling environment, expert understanding of the complex set of regulations within which the organization operates and maintains an awareness of the subtleties of regulations worldwide.

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.

As an Equal Opportunity Employer, we are open to all talent, and adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on US- 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.

Requisition ID: 86764

Recruiter: Chris Venegas

Hiring Manager: Steven B Johnson

Talent Partner: Bianca Hinshaw

Job Level: ED

Please consult HRAnswers for more information on job levels.