Senior Regulatory Affairs Associate

Overview

Senior Regulatory Affairs Associate responsible for regulatory lifecycle management and regulatory maintenance submissions for approved drug products across multiple markets.

What you'll do

• Handle lifecycle management of approved drug products (small molecules and biologicals, including vaccines and monoclonal antibodies).
• Prepare and deliver regulatory maintenance submissions from global and/or regional perspectives.
• Manage CMC-related health authority queries and prepare author responses to requests.
• Author and review CMC components of Marketing Authorization Applications and variations for EU filings (DCP/MRP/National procedures).
• Conduct regulatory review of DMFs, batch records, specifications, and stability data for compliance.
• Support submission planning and provide status updates to stakeholders.
• Prepare, review, and submit safety variations and perform post-approval CMC updates.

What you'll need

• 5+ years of experience in lifecycle management of approved drug products.
• Good understanding of regulatory framework and regional trends for various application/procedure types.
• Working knowledge of EU/US regulatory procedures including post-approval requirements.
• Experience with CMC-related health authority queries and author responses.
• Familiarity with EU/US pharmaceutical legislation and guidance linked to regulatory CMC aspects in ICH countries.
• Working knowledge of regulatory information management systems (RIMS), e.g., Veeva Vault.
• Strong communications skills to guide and mentor team members and work independently.

Details

• Location: India-Bengaluru-Remote.