AGM Regulatory Affairs ( Clinical Trial / Bioequivalence)

AGM / DGM – Medico Regulatory Affairs

• Department: Medico Regulatory Affairs
• Designation: Assistant General Manager (AGM) / Deputy General Manager (DGM) – Medico
• Regulatory Affairs
• Location: Mumbai
• Reporting To: Vice President – Pharmacovigilance and Medico-Regulatory Affairs

Job Summary

• The AGM/DGM – Medico Regulatory Affairs will be responsible for regulatory strategy, dossier
• preparation, compilation, review, and submission of applications related to Clinical Trials (CT),
• Bioequivalence (BE) studies, Post-Marketing Surveillance (PMS) studies, marketing authorization
• applications, manufacturing permissions, and lifecycle management activities through
• CDSCO/DCGI/SUGAM and other applicable regulatory authorities.

The role requires close coordination with Clinical Research, R&D, Manufacturing/Plant, QA/QC, Supply Chain, and other cross-functional departments to ensure timely regulatory approvals,

compliance, and smooth execution of development and commercial projects.

The incumbent will act as the primary regulatory coordination point between the Medico-regulatory Affairs Department and CDSCO/DCGI for study-related submissions, approvals, regulatory communications, and query management.

Key Responsibilities

• 1. Clinical Trial / Bioequivalence Regulatory Activities
• Preparation, compilation, review, and submission of regulatory dossiers for:
• o Clinical Trial (CT) applications
• o Bioequivalence (BE) study applications
• o BA/BE protocol amendments
• o Post-Marketing Surveillance (PMS) studies
• o Phase I, II, III, and IV clinical studies
• Submission of:
• o CT/BE NOC applications through SUGAM portal
• o Protocol amendments and additional information requests
• o Clarification responses to CDSCO/DCGI queries
• o Safety-related regulatory communications, where applicable
• o Periodic updates and study status submissions
• o Form CT-10, Form CT-13, Form CT-12 and Form CT-21
• Coordination with Clinical Research teams for timely regulatory submissions and approvals.
• Preparation, compilation and coordination of documents required for Subject Expert
• Committee (SEC) meetings.
• Ensuring regulatory compliance in line with:
• o NDCTR 2019
• o CDSCO/DCGI requirements
• o Indian GCP Guidelines
• o ICMR Guidelines
• o And other applicable regulatory requirements
• 2. Marketing Authorization & Manufacturing Permission Activities
• Preparation of medical rationale documents and submission of applications related to:
• o Marketing authorization permissions
• o Manufacturing permissions (Test license/Import license)
• o New drug applications
• o Fixed Dose Combination (FDC) applications
• o Additional strength/dosage form applications
• o Permission for new indications
• Compilation and review of technical/regulatory documents required for regulatory filings.
• Coordination with Manufacturing/Plant, QA, QC, and R&D teams for collection and review of following data for drug substance and drug products:
• o Batch manufacturing records
• o Process validation documents
• o Stability data
• o Product specifications
• o Analytical documents
• o GMP-related documentation
• Support lifecycle management activities including:
• o Variations/amendments
• o Renewal applications
• o Labeling and packaging updates
• o Regulatory compliance updates
• 3. R&D and Product Development Support
• Provide regulatory assessment and support for:
• o New product development projects
• o Differentiated products
• o Line extensions
• Participate in cross-functional discussions with:
• o Formulation R&D
• o Analytical R&D
• o Clinical Research
• o Business Development
• Provide guidance regarding:
• o Regulatory pathways
• o Clinical/BE study requirements
• o Waiver possibilities
• o Submission strategy
• o Regulatory risk assessment
• Support preparation of regulatory strategies for domestic
• 4. Project Initiation Form (PIF) Activities
• Review, process and tracking of Project Initiation Forms (PIFs).
• Assess regulatory feasibility and submission requirements during project initiation stages.
• Provide regulatory input regarding for
• o Development strategies
• o Documentation requirements
• o Approval timelines
• 5. Regulatory Intelligence & Compliance
• Monitor and interpret updates related to:
• o CDSCO/DCGI regulations
• o NDCTR 2019
• o ICH Guidelines
• o Indian GCP Guidelines
• o Regulatory requirements applicable to clinical research and product approvals
• Share regulatory intelligence updates with internal stakeholders.
• Develop and maintain:
• o Regulatory SOPs
• o Submission trackers
• o Regulatory databases
• o Documentation control systems
• Ensure proper archival and maintenance of regulatory records and submissions.
• 6. Review and approval of domestic and international labelling information
• Review and approval of:
• o Package insert
• o Prescribing information
• o Summary of Product Characteristics (SmPC)
• o Patient Information Leaflet
• 7. Review and approval of Maximum and Minimum Therapeutic Dosages
• Educational Qualification
• M.Pharm
• Additional certification in Regulatory Affairs or Clinical Research will be preferred.

Experience

• AGM Level: 12–15 years of relevant experience in Medico Regulatory Affairs related to
• CDSCO applications.
• DGM Level: 15–18 years of relevant experience with leadership exposure in pharmaceutical
• regulatory affairs related to CDSCO applications.
• Required Skills & Competencies
• Strong knowledge of:
• o CDSCO/DCGI regulations and submission of all types of Forms
• o SUGAM portal operations
• o NDCTR 2019
• o CT/BE regulatory requirements
• o Marketing authorization processes
• o CTD/eCTD documentation
• Strong documentation and dossier compilation skills.
• Experience in handling regulatory submissions through SUGAM portal.
• Good understanding of pharmaceutical product development lifecycle.
• Excellent coordination and communication skills.
• Ability to manage multiple projects and regulatory timelines effectively.
• Good problem-solving and regulatory query handling capability.
• Ability to handle team
• Key Interactions
• Internal
• Clinical Research Department
• Formulation & Analytical R&D
• Manufacturing/Plant
• Quality Assurance (QA)
• Quality Control (QC)
• Supply Chain & Distribution
• Business Development
• Legal/IP Team
• Finance & Purchase Departments
• External
• CDSCO/DCGI
• State FDA Authorities
• Regulatory Consultants
• Manufacturing Partners/Vendors
• Testing Laboratories, where applicable