Novotech, a leading global Contract Research Organization (CRO), is hiring a Senior Regulatory Start-Up Associate in Bangalore. This role is critical in ensuring timely clinical trial approvals by managing ethics and regulatory submissions in compliance with ICH-GCP and local regulations.
Key Responsibilities:
- Serve as the primary contact for Regulatory Start-Up Managers (RSM) and Project Managers (PM) during trial start-up.
- Prepare, review, and submit country and site-level regulatory documents (EC/IRB, Regulatory Authority applications, etc.).
- Ensure compliance with local and international regulatory requirements (ICH-GCP).
- Track submission deadlines and approvals, updating systems with accurate timelines.
- Act as a liaison with Ethics Committees, Regulatory Authorities, and investigative sites.
- Customize Informed Consent Forms (ICFs) as per local regulations.
- Manage clinical trial registrations, amendments, and safety reports.
- Assist in training junior team members and improving regulatory processes.
Qualifications & Experience:
- Graduate in Clinical, Pharmacy, or Life Sciences.
- 3-5 years of regulatory start-up experience in a CRO, pharmaceutical, or clinical research setting.
- Strong knowledge of local and international clinical trial regulations.
- Experience in document preparation, submissions, and approvals.
- Excellent communication and project management skills.
Why Join Novotech?
Novotech is a globally recognized CRO with a strong presence in Asia-Pacific, North America, and Europe. We offer:
- Flexible work options & paid parental leave.
- Inclusive workplace supporting LGBTIQ+, disability, and caregiver needs.
- Career growth in clinical research and biotech.
- ISO 27001 & ISO 9001 certified, ensuring high-quality standards.
How to Apply?
If you are passionate about regulatory affairs and clinical trials, apply now!
📌 Last Date to Apply: June 20, 2025
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