Executive - Regulatory Affairs

Sun Pharma

2-4 years

Not Disclosed

Baroda, Remote, India, India

Openings: 10 May 26, 2026

Job Description

Job Type: Full Time Hybrid Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description: Executive – Regulatory Affairs (Regulatory & Business Continuity)

Company Details

Company: Sun Pharmaceutical Industries Ltd
Business Unit: R&D1 – Regulatory Affairs
Job Grade: G12A
Location: Tandalja, Baroda (India)
Date Posted: May 25, 2026

Job Title

Executive – Regulatory Affairs (Regulatory and Business Continuity)

Role Overview

The Executive – Regulatory Affairs is responsible for supporting regulatory strategy and submission activities for products intended for the Indian market. The role involves coordination with cross-functional teams, preparation and review of regulatory documentation, and compilation of dossiers for product approvals via the SUGAM portal.

Job Objective & Key Responsibilities

1. Regulatory Strategy & Evaluation

Evaluate regulatory strategy for products to be registered in India
Support planning for New Drug (ND), Subsequent New Drug (SND), and Fixed Dose Combination (FDC) applications

2. Cross-Functional Coordination

Coordinate with cross-functional teams to collect required documentation for regulatory submissions
Ensure timely availability of CMC, clinical, and bioequivalence data

3. CMC & Technical Document Review

Review Chemistry, Manufacturing, and Controls (CMC) documents for regulatory dossiers
Ensure compliance with applicable regulatory guidelines
Review specifications for bulk drugs and finished formulations

4. Clinical & Bioequivalence Review

Review clinical trial and bioequivalence study documentation
Ensure alignment with regulatory submission requirements

5. Literature Research & Scientific Justification

Conduct literature searches using scientific databases and regulatory sources
Prepare scientific rationale for safety and efficacy of new drugs/FDCs
Develop evidence-based summaries using published literature

6. Regulatory Documentation & Dossier Preparation

Compile and prepare regulatory dossiers for submission
Prepare executive summaries for SEC (Subject Expert Committee) referrals
Ensure completeness of all CMC, clinical, and BE documentation

7. Regulatory Submission & Filing

File ND/SND/FDC applications via the SUGAM portal
Obtain permissions for:
- Domestic manufacturing
- Marketing authorization
- Clinical trial approvals

8. Labeling & Prescribing Information

Review draft labels, cartons, and packaging materials
Prepare prescribing information based on international regulatory references

Qualifications

Educational Requirement

Master of Pharmacy (M. Pharm)

Experience Requirements

2–4 years of experience in Regulatory Affairs or related pharmaceutical R&D function

Skills & Competencies

Technical Skills

Regulatory affairs processes for Indian market (CDSCO)
CMC documentation review
Clinical trial and bioequivalence evaluation
Dossier preparation and regulatory submissions
Scientific literature review and interpretation

Functional Skills

Strong coordination with cross-functional teams
Documentation and attention to detail
Regulatory compliance understanding
Scientific writing and summarization

Tools & Systems

SUGAM portal (Indian regulatory submission system)
Scientific databases for literature search

Travel Requirement

Not applicable (NA)

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Executive - Regulatory Affairs

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