Duties & Responsibilities

• Regulatory Leadership & Oversight
  • Lead and manage a team of regulatory specialists with clarity and accountability.
  • Drive regulatory excellence by challenging the status quo, enhancing efficiency, and fostering innovative problem-solving.
  • Ensure all regulatory submissions are completed accurately and on time to prevent delays in study start-up.
  • Maintain strong compliance through consistent adherence to evolving regulatory frameworks.
• Study Start-Up & Documentation
  • Support preparation and review of study-specific documents, including protocols, informed consent forms, HIPAA authorizations, and related materials for IRB review.
  • Prepare and submit amendments, continuing reviews, audit responses, adverse event reports, and other IRB-required submissions.
  • Provide guidance for completing conflict-of-interest documentation.
  • Ensure complete, accurate, and inspection-ready regulatory binders for each study.
• Regulatory File Management
  • Oversee maintenance of paper and electronic regulatory files, ensuring thorough documentation and version control.
  • Coordinate with auditors and inspectors during reviews of regulatory files.
  • Provide timely copies of IRB documents to sponsors as needed.
  • Submit generic site materials to the IRB of record.
• Operational Excellence & Continuous Improvement
  • Identify gaps, risks, and vulnerabilities in the start-up process and implement corrective actions proactively.
  • Generate and present regular progress reports to executive leadership.
  • Recommend and execute process improvements to support corporate goals.
  • Demonstrate strong initiative as an innovative, solutions-oriented leader.
• Compliance & Collaboration
  • Stay updated on evolving regulatory trends and partner with site leadership to ensure implementation.
  • Maintain safety and compliance across all regulatory practices.
  • Support training and mentorship to strengthen team skills, consistency, and operational quality.
  • Perform additional duties as assigned.

Required Skills & Abilities

• Proficient in computers, MS Office, multi-line telephone systems, fax, and copier operations.
• Strong capability to excel in a fast-paced environment with minimal supervision.
• Advanced verbal, written, organizational, and interpersonal communication abilities.
• Demonstrated excellence in multitasking, prioritizing, and following written guidelines.
• Effective mentor with proven training and team-building skills.
• Highly detail-oriented with strong problem-solving and strategic decision-making abilities.
• Flexible, adaptable, and able to adjust to changing clinic or project priorities.
• High level of professionalism, accountability, and ownership of responsibilities.
• Advanced understanding of ICH, GCP, and FDA regulatory requirements.

Job Location- South India

Salary - Best in Industry