SENIOR ASSOCIATE – REGULATORY AFFAIRS (CMC)
Location: Bengaluru, India
Department: Regulatory Affairs – Chemistry, Manufacturing & Controls (CMC)
Job Type: Full-Time
JOB OVERVIEW
The Senior Associate – Regulatory Affairs (CMC) is responsible for managing regulatory submissions, lifecycle maintenance activities, CMC dossier preparation, and regulatory compliance for pharmaceutical and herbal products. The role involves preparing and reviewing Modules 2 and 3 of CTD dossiers, coordinating product registrations, supporting global regulatory filings, and ensuring compliance with regional regulatory requirements.
KEY RESPONSIBILITIES
Regulatory Submission Management
Manage preparation and submission of:
New Product Registrations
Post-Approval Variations
Line Extensions
Renewal Applications
Track regulatory submissions through approval.
Coordinate responses to health authority queries.
Ensure submissions meet regional regulatory requirements.
CMC Dossier Preparation & Review
Prepare and review:
CTD Module 2 (Quality Overall Summary)
CTD Module 3 (Quality Documentation)
Ensure technical accuracy and completeness of CMC documentation.
Review manufacturing, formulation, analytical, and stability data.
Product Lifecycle Management
Manage regulatory activities throughout the product lifecycle.
Support change control implementation.
Coordinate post-approval regulatory submissions.
Maintain regulatory records and submission history.
Product Quality Review (PQR)
Prepare and review Product Quality Review (PQR) reports.
Compile summary reports of variations submitted during specified periods.
Ensure compliance with SOP requirements.
Labeling & Claims Review
Review formulations and ingredient compositions.
Generate ingredient lists according to regulatory standards.
Evaluate product claims for compliance.
Compile and review labeling components as per SOPs.
Regulatory Strategy & Intelligence
Develop local and regional regulatory strategies.
Monitor regulatory updates and industry trends.
Promote regulatory intelligence initiatives.
Support business expansion through regulatory planning.
Health Authority Interaction
Maintain professional relationships with regulatory agencies.
Coordinate responses to regulatory queries.
Support inspections and audits when required.
Ensure timely communication with health authorities.
Product Development Support
Support herbal product development activities.
Provide regulatory input during product development stages.
Review formulation changes and product specifications.
Assist with new product launch activities and tender applications.
KEY DELIVERABLES
CTD Module 2 Preparation & Review
CTD Module 3 Preparation & Review
Product Registration Submissions
Post-Approval Variations
Product Quality Reviews (PQR)
Labeling Documentation
Ingredient List Reviews
Regulatory Strategy Execution
Regulatory Compliance Maintenance
EDUCATIONAL QUALIFICATIONS
Required
Bachelor’s Degree in:
Pharmacy (B.Pharm)
Life Sciences
Pharmaceutical Sciences
Preferred
Master’s Degree in:
Pharmacy (M.Pharm)
Regulatory Affairs
Pharmaceutical Sciences
Life Sciences
EXPERIENCE
Required
4–6 years of Regulatory Affairs experience.
Experience in CMC regulatory documentation.
Preferred
Experience with:
EU Regulatory Filings
CIS Region Regulatory Filings
Herbal Product Development
Product Lifecycle Management
CTD Dossier Preparation
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