AGM Regulatory Affairs ( Clinical Trial / Bioequivalence)
Digital Marketing/Marketing
Job Description
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.
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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
Skills
MarketingIf an employer asks you to pay any kind of fee, please notify us immediately. Jobaaj does not charge any fee from the applicants and we do not allow other companies also to do so.
Important dates & deadlines?
Application Deadline
27 Jul 26, 05:33 PM IST
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