Study Start-up and Regulatory Submission Manager

7 days ago


Navi Mumbai, Maharashtra, India Trigent Software Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Job Title: Study Start-up and Regulatory Submission Manager

Location: Navi Mumbai, India

Experience Required: 5 10 years

Employment Type: Full-Time

Working Days: 2nd & 4th Saturdays; All Sundays Off

Job Description

We are seeking an experienced Study Start-up and Regulatory Submission Manager to join our clinical operations team in Navi Mumbai. The ideal candidate should have strong expertise in India-specific clinical trial operations, with proven experience managing regulatory submissions and study start-up activities.

Key Responsibilities:

  • Lead and manage Clinical Trial Applications (CTA) and regulatory submissions in compliance with Indian regulatory requirements.
  • Drive clinical study start-up activities, including site identification, feasibility, and activation.
  • Coordinate with ethics committees and clinical trial sites to ensure smooth and timely approvals.
  • Prepare, review, and submit study-related documents to DCGI (Drug Controller General of India) and other relevant authorities.
  • Ensure compliance with ICH-GCP guidelines, local regulations, and company SOPs throughout the process.
  • Collaborate with cross-functional teams to ensure on-time study initiation.

If you or someone you know fits this role, apply directly through the job post or share your resume



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