Executive - Regulatory Affairs

Why This Role Matters

The Regulatory Affairs Executive plays a vital role in ensuring that drug substances and drug products receive timely regulatory approvals in India. In a highly regulated pharmaceutical environment, accurate dossier compilation, regulatory strategy evaluation, and compliant submissions are critical for product commercialization and patient access.
This position directly supports business continuity by managing approvals from Indian regulatory authorities and ensuring adherence to applicable guidelines. By coordinating with cross-functional teams and regulatory bodies, the role ensures that products meet all statutory requirements before launch and throughout their lifecycle.
At Sun Pharmaceutical Industries Ltd., regulatory professionals are encouraged to take ownership of their work, continuously improve processes, and contribute to building a strong compliance-driven culture.

Job Description

The Regulatory Affairs Executive will be responsible for evaluation, compilation, and submission of regulatory dossiers to CDSCO-HQ and CDSCO-Zonal offices for obtaining approvals related to drug substances and drug products in India.
The role involves reviewing Chemistry, Manufacturing and Controls (CMC) documentation, preparing regulatory applications, coordinating corrections with internal departments, and managing submission processes through the regulatory authority portal.
The position also includes handling clinical trial permissions, bioequivalence (BE) approvals, manufacturing and marketing permissions, import licenses, post-approval changes, and regulatory lifecycle management activities. The candidate will ensure accurate and timely documentation while maintaining compliance with Indian regulatory frameworks.

Key Features of the Role:

• Position: Regulatory Affairs Executive – India Submissions
• Qualification: M.Pharm
• Experience Required: Minimum 3 years in India Regulatory Affairs
• Exposure to CDSCO-HQ and Zonal office submissions
• Involvement in CT, BE, import, and marketing approvals
• Hands-on experience in dossier compilation and regulatory portal submissions
• Opportunity to manage post-approval lifecycle activities

Responsibilities

• Evaluate regulatory strategies for product registration in India
• Review CMC and supporting documentation for completeness and compliance
• Coordinate with R&D, QA, Manufacturing, and Clinical teams for documentation corrections
• Prepare cover letters and regulatory applications
• Compile regulatory dossiers and submit via regulatory authority portal
• Manage Clinical Trial (CT) and Bioequivalence (BE) permissions
• Obtain domestic manufacturing and marketing approvals
• Handle import and marketing approval applications
• Compile IPC testing dossiers and coordinate laboratory submissions
• Manage Phase IV Clinical Trial applications
• Process post-approval changes and lifecycle submissions
• Handle additional site notification and approval
• Obtain BE permissions for export registration
• Apply for permissions to manufacture or import drugs for examination, testing, or analysis
• Review product label artworks and coordinate required corrections

Required Qualifications

Candidates must demonstrate strong technical knowledge of Indian regulatory procedures and documentation standards.

Educational Requirements:

• M.Pharm (Mandatory)

Experience and Skills:

• Minimum 3 years of relevant experience in India Regulatory Affairs
• Hands-on experience with CDSCO submissions
• Strong understanding of CMC documentation
• Familiarity with CT, BE, and import licensing processes
• Experience in regulatory portal submissions
• Excellent documentation and attention to detail
• Strong cross-functional coordination skills
• Ability to manage multiple submissions under timelines

Salary Insights

Compensation will be aligned with industry standards for professionals with 3+ years of India Regulatory Affairs experience. Salary may vary depending on expertise in CDSCO submissions, lifecycle management, and regulatory strategy handling. Additional benefits and career progression opportunities are provided as per company policy.

Company Overview

Sun Pharmaceutical Industries Ltd. is one of the world’s leading specialty generic pharmaceutical companies with a strong presence in India and global markets. The company is known for its commitment to quality, compliance, innovation, and patient-centric healthcare solutions.
Sun Pharma fosters a growth-oriented culture where employees are encouraged to continuously improve, take ownership of responsibilities, and collaborate effectively to achieve shared goals.

FAQs

Q1. Is prior experience in CDSCO submissions mandatory?
Yes, hands-on experience in CDSCO submissions is required.

Q2. What qualification is mandatory for this role?
M.Pharm is mandatory.

Q3. Does the role involve lifecycle management activities?
Yes, the role includes post-approval changes and lifecycle submissions.

Q4. Is clinical trial exposure required?
Yes, experience handling CT and BE permissions is important.

Q5. Is this role limited to documentation?
No, it also involves regulatory coordination, strategy evaluation, and artwork review.

Application Tip

• Highlight specific CDSCO submissions handled
• Mention CT, BE, and import license experience clearly
• Showcase CMC documentation review expertise
• Provide examples of successful dossier compilation
• Emphasize cross-functional coordination experience
• Ensure your resume clearly reflects India regulatory exposure