Regulatory Affairs Associate

Roles and Responsibilities :

• Manage drug regulatory affairs, including dossier preparation, submission, and approvals from US FDA (US Food and Drug Administration).
• Coordinate with cross-functional teams to ensure timely completion of regulatory requirements throughout the product lifecycle.
• Prepare and review variation applications, renewals, and other documentation related to drug regulations.
• Provide guidance on regulatory compliance matters to internal stakeholders.

Job Requirements :

• 5-7 years of experience in pharmaceutical industry with expertise in drug regulatory affairs.
• Strong understanding of USFDA guidelines and regulations governing drug development process.
• Proficiency in preparing dossiers for regulatory submissions, including eCTD format.