Location: Ahmedabad
Qualification: B.Pharm (Mandatory), M.Pharm (Preferred)
Experience: 5-8 Years
About the Role
We are looking for a Regulatory Affairs qualified with strong experience in Post-Approval Regulatory Affairs for Injectable Products. The role involves managing regulatory submissions, lifecycle maintenance activities, and ensuring compliance with USFDA and ICH requirements for sterile and complex injectable products.
Key Responsibilities
Regulatory Submission Management
• Prepare, review, compile, and support post-approval regulatory submissions for injectable products.
• Manage Annual Reports, CBE-0, CBE-30, PAS, and other post-approval submissions as per USFDA requirements.
• Ensure timely preparation and submission of regulatory documents in line with approved regulatory strategies and business timelines.
• Perform preliminary review of submission packages to ensure completeness, accuracy, and regulatory compliance.
Regulatory Compliance & Strategy
• Evaluate change cases and assess regulatory filing requirements based on ICH guidelines and USFDA post-approval regulations.
• Support regulatory decision-making related to manufacturing, process, formulation, packaging, and quality-related changes.
• Monitor regulatory requirements and provide recommendations to ensure ongoing product compliance.
Documentation & Reporting
• Draft Annual Reports with required supporting information as per USFDA guidance.
• Maintain regulatory records, submission trackers, and product lifecycle documentation.
• Ensure all regulatory information is accurately maintained and archived as per internal procedures.
Cross-Functional Collaboration
• Coordinate with Manufacturing, Quality Assurance, Quality Control, R&D;, Supply Chain, and other cross-functional teams for timely collection of submission documents.
• Ensure effective communication and follow-up to prevent delays in regu