Sun Pharma is a leading global pharmaceutical company headquartered in India, specializing in generic and specialty medicines. With a strong presence in over 100 countries, Sun Pharma is known for its innovation, quality, and regulatory excellence. The company fosters a collaborative work environment and is consistently recognized as an employer of choice.
Job Highlights
✅ Experience in Regulatory Operations with expertise in Clinical Trial Applications (CTA)
✅ Knowledge of eCTD/CTIS structure and global submission requirements
✅ Manage lifecycle of CTAs (EU, LATAM, USA, Canada, ROW)
✅ Collaborate on submission strategies and process improvements
✅ Hybrid work model in Mumbai/Gurugram
Job Description
Role & Responsibilities:
- Handle Regulatory Operations for NCE/BLA programs, including CTA applications (EU, LATAM, USA, Canada, ROW).
- Manage CTIS (Clinical Trial Information System) and eCTD publishing for all modules.
- Ensure compliance with Global Regulatory filing requirements and stay updated on eCTD/CTIS guidelines.
- Collaborate with Regulatory Strategists to define submission timelines and strategies.
- Prepare Regulatory Management Plans (RMP) and Submission Content Plans for CTAs.
- Oversee lifecycle management of CTAs (in-house & outsourced activities).
- Act as the technical coordinator for CTA submissions, RFIs (Request for Information), and notifications.
- Maintain document archival and ensure proper submission tracking.
- Assist in process improvements to meet evolving CTIS requirements.
- Generate regulatory metrics and reports as required.
- Support additional Regulatory Operations tasks, including Clinical Trial Disclosure and eCTD publishing.
How to Apply
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