Executive – Regulatory Affairs & Business Continuity
Location: Vadodara (Baroda), India
Business Unit: R&D – Regulatory Affairs
Job Grade: G12A
Employment Type: Full-Time
Company: Sun Pharmaceutical Industries Ltd.
Job Summary
The Executive – Regulatory Affairs & Business Continuity is responsible for supporting regulatory strategy, dossier preparation, regulatory submissions, and lifecycle management activities for pharmaceutical products in the Indian market. The role involves coordination with cross-functional teams, review of CMC, Clinical Trial, and Bioequivalence documentation, preparation of regulatory dossiers, and ensuring compliance with applicable regulatory requirements.
The incumbent will contribute to obtaining regulatory approvals for new drugs, fixed-dose combinations (FDCs), supplemental applications, and clinical trial applications while supporting business continuity and regulatory compliance initiatives.
Key Responsibilities
Regulatory Strategy & Product Registration
Support the development and execution of regulatory strategies for pharmaceutical products intended for registration in India.
Evaluate regulatory requirements and approval pathways for:
New Drugs (ND)
Subsequent New Drugs (SND)
Fixed Dose Combinations (FDCs)
Clinical Trial Applications
Marketing Authorization Applications
Monitor regulatory developments and assess their impact on product registration strategies.
Dossier Preparation & Regulatory Submissions
Coordinate with cross-functional departments to collect required documentation for regulatory submissions.
Compile, review, and prepare regulatory dossiers in accordance with applicable regulatory guidelines.
Ensure timely submission of complete and accurate regulatory applications.
Manage dossier lifecycle activities and regulatory correspondence.
CMC Documentation Review
Review Chemistry, Manufacturing, and Controls (CMC) documentation for inclusion in regulatory dossiers.
Ensure compliance of CMC data with Indian regulatory requirements and current guidelines.
Verify completeness, accuracy, and consistency of manufacturing and quality documentation.
Support resolution of CMC-related regulatory queries.
Specifications & Quality Documentation
Review specifications for:
Active Pharmaceutical Ingredients (APIs)
Bulk Drugs
Finished Pharmaceutical Products
Ensure specifications meet regulatory expectations and quality requirements.
Coordinate with Quality Assurance and Analytical Development teams for documentation updates.
Clinical & Bioequivalence Documentation Review
Review clinical trial and bioequivalence (BE) study documentation for regulatory submissions.
Evaluate:
Clinical Study Reports
Bioequivalence Reports
Protocols
Investigator Brochures
Clinical Justifications
Ensure compliance with applicable regulatory and ethical requirements.
Literature Research & Medical Evaluation
Conduct scientific and regulatory literature searches using relevant databases and published sources.
Review scientific evidence to support regulatory strategies.
Prepare safety and efficacy rationales for:
New Drugs
Fixed Dose Combinations
Regulatory Justifications
Analyze published literature and regulatory precedents to support submission activities.
SEC Documentation & Regulatory Defense Support
Prepare executive summaries and scientific justifications for:
Subject Expert Committee (SEC) Referrals
Regulatory Presentations
Product Review Meetings
Support preparation of briefing documents and regulatory defense materials.
Assist in addressing regulatory agency questions and requests.
Regulatory Systems & Submission Management
Prepare and submit applications through the SUGAM Portal for:
Manufacturing Permissions
Marketing Authorization Applications
Clinical Trial Permissions
Regulatory Amendments and Variations
Track submission status and regulatory approvals.
Maintain regulatory records and submission documentation.
Labeling & Prescribing Information Review
Review and approve:
Product Labels
Carton Artwork
Package Inserts
Draft Specimens
Prepare prescribing information by reviewing:
International Product Labels
Global Prescribing Information
Regulatory Guidelines
Ensure labeling compliance with Indian regulatory requirements.
Cross-Functional Collaboration
Collaborate closely with:
Regulatory Affairs
Formulation Development
Analytical Development
Quality Assurance
Clinical Research
Bioequivalence Teams
Medical Affairs
Manufacturing
Supply Chain
Ensure timely collection and review of required submission documents.
Facilitate effective communication across stakeholders to support regulatory timelines.
Educational Qualifications
Required
Master of Pharmacy (M.Pharm)
Preferred
Specialization in:
Regulatory Affairs
Pharmaceutics
Pharmaceutical Chemistry
Pharmaceutical Analysis
Clinical Pharmacy
Quality Assurance
Experience Requirements
Required
2–4 years of experience in:
Regulatory Affairs
Dossier Compilation
Product Registration
Regulatory Submissions
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