Regulatory Affairs Executive

Why This Role Matters
The Regulatory Affairs Executive plays a critical role in securing timely regulatory approvals for drug substances and drug products in India. By evaluating regulatory strategies, compiling dossiers, and coordinating cross-functional documentation, this role ensures compliance with CDSCO requirements and supports uninterrupted product registration, manufacturing, and marketing approvals. The position directly contributes to business continuity and regulatory excellence.

Job Description
Sun Pharmaceutical Industries Ltd. is seeking a Regulatory Affairs Executive responsible for evaluation, compilation, and submission of regulatory dossiers to CDSCO-HQ and CDSCO-Zonal offices. The role involves handling clinical trial permissions, bioequivalence approvals, import and marketing authorizations, post-approval changes, and regulatory documentation review for India submissions.

Key Features of the Role
• Position: Regulatory Affairs Executive
• Function: India Regulatory Affairs
• Qualification: M.Pharm
• Experience Required: Minimum 3 years (relevant experience)
• Industry: Pharmaceutical Manufacturing
• Employment Type: Full-Time

Responsibilities
• Evaluate regulatory strategies for products to be registered in India
• Review CMC and other technical documents
• Coordinate with cross-functional teams for documentation corrections
• Prepare cover letters and regulatory application documents
• Compile and submit dossiers on CDSCO portal for approvals including:
• Clinical Trial (CT) permissions
• Bioequivalence (BE) permissions
• Domestic manufacturing and marketing approvals
• Import and marketing approvals in India
• Compile IPC testing dossiers and coordinate for sample readiness and lab submission
• Manage post-approval changes
• Handle Phase IV clinical trial applications
• Process additional site notifications/approvals
• Manage BE permissions for export registration
• Obtain permissions for manufacture/import of drugs for examination, test, or analysis (Forms CT-10/12/13, Form-11, CT-17, Form-8)
• Review product label artworks and coordinate corrections

Required Qualifications
• Strong knowledge of Indian regulatory framework and CDSCO requirements
• Understanding of CMC documentation and dossier compilation

Educational Requirements
• M.Pharm (Mandatory)

Experience and Skills
• Minimum 3 years of relevant regulatory affairs experience
• Experience in CT, BE, import/export, and marketing authorization submissions
• Familiarity with CDSCO online submission portal
• Strong documentation and dossier compilation skills
• Cross-functional coordination ability
• Attention to regulatory detail and compliance standards

Salary Insights
Compensation will be offered as per industry standards and candidate experience.

Company Overview
Sun Pharmaceutical Industries Ltd. is one of India’s leading pharmaceutical companies, committed to fostering professional growth and innovation. With a strong regulatory and manufacturing footprint, Sun Pharma supports employees in building impactful careers while contributing to global healthcare solutions.

FAQs

Q1. Is CDSCO submission experience mandatory?
Yes, relevant experience in CDSCO submissions is required.

Q2. Is clinical trial documentation exposure needed?
Yes, experience in CT and BE permissions is part of the role.

Q3. What qualification is required?
M.Pharm is mandatory.

Q4. Is artwork review part of regulatory responsibilities?
Yes, product label artwork checking and coordination is included.

Q5. What type of approvals will be handled?
CT, BE, import permissions, marketing approvals, post-approval changes, and testing permissions.

Application Tips
• Highlight CDSCO portal submission experience
• Mention CT/BE application handling exposure
• Showcase CMC document review expertise
• Include experience with import/export regulatory permissions
• Emphasize cross-functional coordination and dossier compilation accuracy