Deputy General Manager - Regulatory Affairs

GUFIC BIOSCIENCES LIMITED; Mumbai; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

GUFIC BIOSCIENCES LIMITED in Mumbai seeks an experienced Regulatory Affairs specialist to manage CMC documentation and regulatory submissions.

You will review and compile drug product dossiers, develop regulatory strategies, and coordinate with QA, Production and external agencies to ensure timely approvals. The role requires meticulous attention to detail and strong knowledge of global regulatory requirements, with responsibility for DMFs, RLDs, and response to queries.

Responsibilities

• Review and compile drug product dossiers for regulatory submissions.
• Prepare and review CMC regulatory modules for global authorities.
• Develop CMC regulatory strategies for development and registration.
• Assess specifications, stability, protocols, and technical docs for injectables.
• Review DMFs and RLD approval packages for compliance.
• Respond to regulatory queries with coordinated cross-functional teams.
• Support pre-audit activities and USFDA inspections.
• Maintain documentation and regulatory correspondence per procedures.

Job description

• 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 efficient 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.