Company: Paraxel India Ltd
The candidate should have 5+ years of relevant experience in Vaccines / Biologics.
Supported the CMC activities related to Vaccine/Biologic manufacturing and control including authoring of submission dossiers related to:
- New application, post approval variations
- Understanding of EU/CA/WHO/US regulations & guidance allowing appropriate review and compilation of data to appropriate standards & requirements
- Experienced in CTD update/authoring ( CTD Module 2&3)
- Handled and responded Health Authorities Request
- US & CA Annual reports, Renewals, PQVAR, APR
- Assessment of the impact of the regulation Medical Device on marketed products
- Assessment of the Change Controls and associated technical dossiers
- Excellent individual project management and communication skills
- Veeva tool experience.
( And / or)
Labeling
- Authoring content of the label (EU, Canada, AU/NZ & US from the CCDS excl. artwork),
- Able to understand the science, and lead labeling meetings and present the label to Sr mgt.
- Familiarity with labeling templates (QRD) for multiple vaccines all in English.
Qualifications
Candidate should have 5+ years of relevant experience in Vaccines / Biologics.
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