Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help lifesaving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory, and therapeutic expertise, our team of more than 21,000 global professionals works in partnership with biopharmaceutical leaders, emerging innovators, and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere.
Job Information
| Post Name | Qualification | Experience | Job Location |
| Regulatory Affairs Associate | B. Pharma/ M. Pharma/ Life science | 2 Years | Bengaluru |
Job Description
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
End Date: 20th August, 2023
