International Regulatory Labelling Lead
3 months ago
Job Title: InternationalRegulatory Labelling Lead
Location:Remote
Duration: 12months
JobDescription:
Seeking a Global LabellingProduct Leader (GLPL) to support Pharma products at JanssenR&D. Responsibilities include developing target labellingmanaging updates to Company Core Data Sheets (CCDSs) EUPIs andUSPIs in line with GL CoE and GRA labeling processes. Trainingprovided.
Responsibilities:
- Facilitate labeling negotiations with healthauthorities for EUPI and USPI.
- FacilitateLabeling Working Group (LWG) reviews and Labeling Committee (LC)endorsements.
- Prepare and finalizesubmissionready EUPI and USPI.
- Process locallabeling deviation requests for exUS and exEU markets.
- Prepare updates to CCDS EUPI and USPI for new indicationssafety updates and CMC revisions.
Education & Experience:
- Bachelors degree in a scientific discipline;advanced degree (MS PharmD PhD MD) desirable.
- 6 years in the pharmaceutical industry or healthauthority
- 5 years in regulatory affairs withproduct labeling experience.
- Experienceauthoring text for CCDSs EUPIs and USPIs and liaising withexperts.
Skills:
- Advanced Microsoft Word skills.
- Experience with Documentumbased document managementsystems.
- Basic Excel and PowerPointskills.
- Excellent project management verbaland written communication skills.
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