Regulatory Affairs Consultant

Biologic/Small Molecules CMC

7 to 9 years of experience

Supported the CMC activities related to Vaccine/Biologic/Small Molecules 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 1, 2&3)

-             Handled and responded Health Authorities Request

-             US & CA Annual reports, Renewals, PQVAR, APR

-             Assessment of the Change Controls and associated technical dossiers

-             Excellent individual project management and communication skills

-             Veeva tool experience