Regulatory Affairs Associate
2 weeks ago
Bengaluru, India
**Job ID** 84359BR
**Category** Regulatory / Consulting
**ABOUT THIS ROLE**:
**Experience: Biologic CMC**
2 years of experience
Supported the CMC activities related to Vaccine/Biologic manufacturing and control including authoring of submission dossiers related to:
- 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
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