Regulatory Affairs Specialist

About UsefulBI:

UsefulBI is a leading AI-driven data solutions provider specializing in data engineering, cloud transformations, and AI-powered analytics for Fortune 500 companies. We help businesses turn complex data into actionable insights through our innovative products and services.

Role Overview:

We are seeking a Regulatory Affairs Subject Matter Expert (SME) with 58 years of experience in the pharmaceutical or life sciences industry. The ideal candidate will provide strategic and operational expertise in global and regional regulatory requirements and submissions. This role involves collaborating with cross-functional teams across clinical, CMC, medical, and quality functions to ensure compliance with health authority regulations.

Key Responsibilities:

• Provide subject matter expertise in global and regional regulatory requirements and submissions.
• Expertise in CMC requirements and their impact on regulatory 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.