- 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.
- 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.
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Head Global Labelling, Promotion - Anderlecht, België - UCB
Beschrijving
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
Interested? For this position you'll need the following education, experience and skills:
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 with 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.
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.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on on EMEA- Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
