Regulatory Affairs Associate

2 weeks ago


Bengaluru, India Parexel Full time

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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