Job title: Senior Regulatory Affairs Associate

Company: Parexel

Job description: Candidate should have 5+ years of relevant experience in Vaccines / Biologics. CMC: Supported the CMC activities related to Vaccine/Biologic manufacturing and control including authoring of submission dossiers related to: – New application, post appr

Candidate should have 5+ years of relevant experience in Vaccines / Biologics. CMC: 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.

Expected salary:

Location: Bangalore, Karnataka

Job date: Wed, 23 Mar 2022 23:43:38 GMT

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