Senior Regulatory Affairs Associate – CMC Biologics

Job Description

Contribute to the creation and submission of regulatory documents from both global and regional standpoints. Responsible for the preparation and revision of Marketing Authorization Applications & Variations intended for regulatory submission.

Qualifications

1. Possess 5 to 8 years of experience in managing new registrations, life cycle management, and renewals of Biologicals, Vaccines, recombinant protein molecules, monoclonal antibodies, plasma derived products, and small molecules across diverse markets. 2. Demonstrate a strong understanding of the regulatory framework, including regional trends for various application types and procedures applicable to small and large molecules in all regions. 3. Exhibit strong communication and collaboration capabilities. 4. Capable of working autonomously.

Benefits

- Flexible work options. - Opportunities for professional growth.