International Regulatory Labelling Lead (remote)
Canada, Canada
Job Description
Job Title: International Regulatory Labelling Lead
Location: Remote
Duration: 12 months:
Seeking a Global Labelling Product Leader (GLPL) to support Pharma products at Janssen R&D. Responsibilities include developing target labelling, managing updates to Company Core Data Sheets (CCDSs), EUPIs, and USPIs in line with GL CoE and GRA labeling processes. Training provided.Responsibilities:
- Facilitate labeling negotiations with health authorities for EUPI and USPI.
- Facilitate Labeling Working Group (LWG) reviews and Labeling Committee (LC) endorsements.
- Prepare and finalize submission-ready EUPI and USPI.
- Process local labeling deviation requests for ex-US and ex-EU markets.
- Prepare updates to CCDS, EUPI, and USPI for new indications, safety updates, and CMC revisions.
- Bachelor\'s degree in a scientific discipline; advanced degree (MS, PharmD, PhD, MD) desirable.
- 6+ years in the pharmaceutical industry or health authority
- 5+ years in regulatory affairs with product labeling experience.
- Experience authoring text for CCDSs, EUPIs, and USPIs, and liaising with experts.
- Advanced Microsoft Word skills.
- Experience with Documentum-based document management systems.
- Basic Excel and PowerPoint skills.
- Excellent project management, verbal, and written communication skills.
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Job Detail
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Job IdJD2323343
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationCanada, Canada
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EducationNot mentioned