Regulatory Affairs Specialist

About UsefulBI:

data engineering, cloud transformations, and AI-powered analytics

Role Overview:

Regulatory Affairs Subject Matter Expert (SME)

Key Responsibilities:

• Provide subject matter expertise in global and regional regulatory requirements and submissions.
• Review and interpret regulatory guidelines to support product development and lifecycle management.
• Partner with cross-functional teams (clinical, CMC, medical, and quality) to ensure compliance with applicable regulations.
• Prepare, review, and maintain regulatory documents including INDs, NDAs, MAAs, CTDs, and other agency submissions.
• Support responses to health authority queries and regulatory audits.
• Track and implement changes in regulatory frameworks impacting ongoing and future submissions.

Required Skills:

• Strong understanding of global regulatory processes (USFDA, EMA, CDSCO, etc.).
• Hands-on experience with eCTD submissions and regulatory strategy development.
• Excellent analytical, documentation, and communication skills.