Parexel opening for Senior Regulatory Affairs Associate Job

Senior Regulatory Affairs Associate

India, RemoteA

dditional Locations: Bengaluru, Karnataka, India

Job ID R0000018827

Category Regulatory / Consulting

As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.

We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.

ABOUT THIS ROLE

Senior Regulatory Affairs Associate

Biologic/Small Molecules CMC

Relevant years of experience

Supported the CMC activities related to Vaccine/Biologic/Small Molecules 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