Study Start-up and Regulatory Submission Manager
- MNC BPO
- 5 - 10 years
- Mumbai
- 5 months ago
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Job Description
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 at na****b@tr****t.com
Job Classification
Industry: Clinical Research / Contract ResearchFunctional Area / Department: Healthcare & Life SciencesRole Category: Healthcare & Life Sciences - OtherRole: Healthcare & Life Sciences - OtherEmployement Type: Full timeContact Details:
Company: TrigentLocation(s): Mumbai
Keyskills: Dcgi CTA Clinical Trials Regulatory Submissions
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