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Regulatory Labeling Lead

Remote:

Full Remote

Experience:

Senior (5-10 years)

Work from:

New Jersey (USA), United States

Offer summary

Qualifications:

6+ years in Regulatory Affairs product labeling, Bachelor's Degree in Scientific field, Advanced Scientific Degree (MS, PhD, MD or PharmD).

Key responsabilities:

Develop target labeling for Pharma products
Manage updates to CCDSs, EUPIs and USPIs
Facilitate negotiations with Health Authorities
Coordinate Labeling Working Group reviews
Prepare submission-ready EUPI and USPI

Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/

51 - 200 Employees

See more Katalyst HealthCares & Life Sciences offers

Job description

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.