Deputy General Manager - Regulatory Affairs
Gufic Biosciences · Mumbai · onsite · Posted 66d ago
Undisclosed10–20 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
- 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.
Sourced from naukri
Skills
Regulatory AffairsDossier PreparationLegal Documentation
About Gufic Biosciences
Gufic Biosciences
Pharma
652
employees
1970
56 years old
Mumbai, Maharashtra
India
₹3.9L PA avg
Avg at Gufic Biosciences
About
A leader in pharmaceuticals, producing innovative herbal products and APIs, including lyophilized injections, to cater to healthcare needs.
Industries
PharmaBiotech & Life sciences
Employee ratings
10 reviews
3.3/ 5
Culture
3.1
Career growth
2.9
Work-life
3.1
Employees rate it well for
Overall Company33Work-Life Balance32
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