Senior Regulatory Affairs Associate – CMC Biologics

This is a fully remote position, open to applicants in India.

📋 Description

• Assist in the preparation and execution of regulatory submissions from both a global and regional viewpoint.

• Prepare and evaluate Marketing Authorization Applications and Variations for submission.

⛳️ Requirements

• 5 to 8 years of experience in managing new registrations, life cycle management, and renewals for Biologicals, Vaccines, recombinant protein molecules, monoclonal antibodies, plasma-derived products, and small molecules across various markets.

• Strong comprehension of the regulatory landscape, including regional trends related to different types of applications and procedures for both small and large molecules across all regions.

• Excellent communication and teamwork abilities.

• Capacity to work autonomously.

🏝️ Benefits

• Flexible work arrangements.

• Opportunities for professional development.