Senior Regulatory Affairs Associate

Senior Regulatory Affairs Associate

Experience: Biologic CMC

5+ years of experience

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 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

Education:

Bachelors/Masters in Pharmacy OR Bachelors/ Masters in any of Life