Senior Executive - Regulatory Affairs

Sun Pharmaceutical Industries, Inc.; India; On-site; INR 600,000 - 900,000; Full time

Job summary

Sun Pharma seeks a Senior Executive-Regulatory and Business Continuity to lead regulatory data reviews, dossier compilation, and communications with authorities. You will coordinate responses to deficiency letters, provide cross-functional regulatory support, and manage eCTD submissions across major regions.

The role requires 1–5 years in regulatory affairs, a M. Pharm, and hands-on experience with US FDA, Health Canada, and European submissions.

Qualifications

• M. Pharm degree required.
• 1-5 years of regulatory affairs experience.
• Experience with US FDA, Health Canada, Europe submissions.

Responsibilities

• Review all data and documents related to product registrations for various health authorities.
• Compile registration dossiers for submission to health authorities (US FDA, Health Canada, Europe, Australia/New Zealand, Japan, Israel).
• Prepare responses to deficiency letters from agencies.
• Provide regulatory support to cross functional departments.
• Prepare and submit scientific advice to health authorities.
• eCTD compilation, verification and submission.
• Review, preparation and submission of annual reports to US FDA.
• Review, preparation and submission of post approval supplements to US FDA.

Skills

Regulatory affairs

Documentation

Cross-functional teamwork

Attention to detail

Education

M. Pharm

Tools

eCTD tools

Regulatory databases

Job description

Title: Senior Executive - Regulatory Affairs

Date: Aug 31, 2026

Location: Tandalja - R&D

Company: Sun Pharmaceutical Industries Ltd

Job Title:

Senior Executive-Regulatory and Business Continuity

Business Unit:

R&D1 Regulatory Affairs

Job Grade

G11B

Location :

Dadra

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

J ob Description

• Review all data and documents related to product registrations for various health authorities.
• Compile registration dossiers for submission to various health authorities like – US-FDA, Health Canada, Europe, Australia/New Zealand, Japan and Israel.
• Prepare responses to deficiency letters received from various agencies.
• Provide regulatory support to cross functional departments.
• Prepare and submit scientific advice to various health authorities.
• eCTD compilation, verification and submission through electronic gateway
• Review, preparation and submission of annual reports to US FDA
• Review, preparation and submission of post approval supplements to US FDA

NA

Job Requirements

Educational Qualification

M. Pharm

Experience

Tenure 1- 5 years of experience.

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s)