JAMP Pharma is currently hiring for positions in Regulatory Affairs – eCTD at the levels of Officer / Senior Officer / Executive. This opportunity focuses on professionals who have the expertise to manage and submit regulatory documents using the electronic Common Technical Document (eCTD) format, essential for pharmaceutical compliance.
Key Responsibilities:
- eCTD Compilation and Validation: Handling submissions to Health Canada and the US FDA through ESG gateway, including new submissions (e.g., ANDS/NDS), deficiency responses (Clarifax, SDN, NOD, NON, etc.), supplemental submissions (SANDS, ARs, Safety updates, RMPs, etc.).
- Export Market Submissions: Managing eCTD compilation and validation for international submissions.
- Product Lifecycle Management: Overseeing the eCTD lifecycle of pharmaceutical products.
- Submission Tracking: Maintaining and updating daily submission logs.
- Document Management System: Implementing and maintaining systems for document control and management.
Specifications:
- Department: Regulatory Affairs – eCTD
- Experience Required: 1 – 5 years
- Qualifications: B. Pharma / M. Pharma / M.Sc.
- Location: Ahmedabad, India
Application Process:
Interested candidates should send their profiles to sjani@jamppharma.com.