Application Deadline: May 12, 2025 (TMF Associate I) & May 1, 2025 (Regulatory Operations Assistant II)
Job Description
1. TMF Associate I – Bangalore
Key Responsibilities:
- Manage electronic Trial Master Files (eTMF) for clinical studies, ensuring compliance with regulatory standards.
- Classify and review documents under Smart Inbox and ARC review.
- Conduct visual quality checks on e-documents for clarity and compliance.
- Maintain audit-ready TMF files in line with GCP, ICH guidelines, and company SOPs.
- Identify and resolve operational issues related to TMF.
- Support internal/client audits and implement corrective actions.
- Collaborate with cross-functional teams to ensure client satisfaction.
- Participate in process improvement initiatives for better efficiency.
Qualifications:
- Education: Bachelor’s degree in Life Sciences/Business.
- Experience: 6-12 months in clinical research.
- Skills: Knowledge of GCP, ICH guidelines, Microsoft Office, Adobe Acrobat, and eTMF systems.
- Preferred: Master’s degree or experience in clinical electronic systems.
Work Environment:
- Minimal travel (<10%) for client meetings.
2. Regulatory Operations Assistant II – Pune (Hybrid)
Key Responsibilities:
- Prepare, compile, and review CMC & regulatory documents for global submissions.
- Create/update raw material & packaging specifications.
- Coordinate with cross-functional teams for change control assessments.
- Support financial data management, business plans, and supplier data.
- Assist in global labeling documentation and stability data evaluation.
- Conduct literature surveys for regulatory compliance.
- Manage import license requirements and investigation reports.
- Ensure compliance with regulatory guidelines for pharmaceutical products.
Qualifications:
- Education: Bachelor’s/Master’s in Pharmacy/Life Sciences.
- Experience: 1-2 years in regulatory affairs/pharmaceutical industry.
- Skills: Knowledge of regulatory guidelines, CSV, and quality compliance.
About the Company
A leading global clinical research and regulatory operations firm dedicated to ensuring compliance, quality, and efficiency in pharmaceutical and clinical trial documentation. We offer a dynamic work environment with opportunities for professional growth.
How to Apply
Interested candidates can apply before the deadline:
- TMF Associate I (Bangalore): Apply Here (Deadline: May 12, 2025)
- Regulatory Operations Assistant II (Pune): Apply Here (Deadline: May 1, 2025)
