- Review, compile, publish, and submit drug product dossiers to various regulatory agencies and clients, ensuring accuracy, completeness, and compliance with applicable regulatory requirements.

- Prepare and review high-quality CMC regulatory modules and documentation for submission to global regulatory authorities.

- Develop CMC regulatory strategies for drug product development and registration.

- Assess and evaluate supporting CMC documents, including specifications, stability protocols, study protocols, and other technical documentation for injectable products.

- Review Drug Master Files (Type II DMFs) for suitability and compliance with generic drug applications.

- Review Reference Listed Drug (RLD) approval packages and labeling to identify relevant inputs for drug product development and regulatory documentation.

- Review technical and manufacturing documents, including Pharmaceutical Development Reports (PDR), Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), Process Validation Protocols and Reports, Stability Data, Hold-Time Protocols and Reports, and other relevant CMC documentation.

- Conduct regulatory gap assessments following dossier submissions, query responses, and major amendments; identify potential deficiencies and track closure of identified gaps.





- Evaluate CMC and labeling queries, develop response strategies, and coordinate with relevant stakeholders to ensure timely and comprehensive responses.

- Review, compile, and finalize responses to regulatory queries, ensuring timely submission and supporting productive regulatory approvals.

- Coordinate with and provide regulatory support to cross-functional teams, including Formulation Development, Quality Assurance, Quality Control, Production, Packaging Development, Sales & Marketing, and Purchase.

- Provide regulatory support for pre-audit/pre-inspection activities at manufacturing sites, including preparation and coordination for USFDA inspections.

- Liaise with API suppliers/manufacturers, regulatory partners, and other external stakeholders to address issues and deficiencies identified during regulatory review and evaluation of registration dossiers.

- Ensure effective follow-up and coordination with internal and external stakeholders to facilitate timely submission, query resolution, and product registration/approval.

- Maintain effective documentation, tracking, and regulatory correspondence in accordance with established procedures and applicable regulatory requirements.

📌 Deputy General Manager - Regulatory Affairs (Mumbai)
🏢 Gufic Biosciences
📍 Mumbai