Insight Global is seeking a Global Regulatory Labeling Product Lead to join a large Pharmaceutical client. This role will support Pharma products specifically in the Global Labeling department. Key responsibilities include developing target labeling, managing updates to Company Core Data Sheets (CCDSs), Centralized/MRP EUPIs, and USPIs. The role aligns with GL CoE and GRA end-to-end labeling processes
Responsibilities:
Labeling Negotiations: Facilitate negotiations with Health Authorities for EUPI and USPI related to assigned products. Coordinate Labeling Working Group (LWG) reviews and Labeling Committee (LC) endorsements of labeling documents. Prepare submission-ready EUPI and USPI.
Local Labeling Deviations: Process Local Labeling Deviation requests for assigned products in ex-US and ex-EU markets. Facilitate LWG reviews and LC involvement.
CCDS Updates: Prepare updates to the CCDS, EUPI, and USPI for products in additional therapeutic areas (e.g., new indications, safety updates, CMC revisions). Facilitate LWG reviews and secure LC endorsement for the CCDS, finalizing and releasing it.
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to
HR@insightglobal.com.
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6+ years experience of Regulatory Affairs product labeling in the pharmaceutical industry
Strong background authoring or updating content and text for CCDSs, EUPIs, USPIs for product labeling from scientific source data and regulatory requirements
Experience with labeling deviations, new indications, safety updates, and CMC revisions
Excellent verbal, written and cross functional communication skills
Bachelor's Degree in Scientific related field
Advanced Scientific Degree (MS, PhD, MD or PharmD)
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.