Regulatory Affairs Expert with Biologic CMC Experience
5 days ago
Parexel International Corporation is seeking a seasoned Regulatory Affairs Associate to support the CMC activities related to vaccine and biologic manufacturing and control.
Key Responsibilities:
- Author submission dossiers for new applications, post-approval variations, and understanding of EU/CA/WHO/US regulations & guidance.
- Compile data to appropriate standards & requirements.
- Experience in CTD update/authoring (CTD Module 1, 2&3).
- Handle and respond to Health Authorities Requests.
- Support US & CA Annual reports, Renewals, PQVAR, APR.
Requirements:
- Bachelor's or Master's degree in Pharmacy or Life Sciences.
- 5+ years of experience in Biologic CMC.
Preferred Qualifications:
- Veeva tool experience.
Estimated Salary: $120,000 - $180,000 per year.
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