Responsibilities and Requirements:
- 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).
- Insight Global is seeking a Global Regulatory Labeling Product Led 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.