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

Application Link