Sr. Executive – Regulatory Affairs (eCTD & US FDA) | Sun Pharma, Gurgaon

Pharma Job Hunt; Gurgaon; On-site; INR 950,000 - 1,500,000; Full time

Job summary

Sun Pharma in Gurgaon, Haryana, India invites applications for Executive / Senior Executive – Regulatory Affairs. The role requires 4–6 years of regulatory experience and a B. Pharma/M.

Pharma qualification, with strong expertise in eCTD submissions and global dossier work. You will review data and prepare registrations, compile dossiers for US-FDA, Health Canada, Europe, and other authorities, respond to deficiency letters, and support lifecycle management with cross-functional teams to ensure

Qualifications

• Bachelor's or Master's in Pharmacy with regulatory expertise.
• 4–6 years’ experience in pharmaceutical regulatory affairs.
• Expertise in eCTD, global dossier submissions, and lifecycle management.

Responsibilities

• Review data and documentation for product registrations across global health authorities.
• Compile registration dossiers for submission to agencies including US-FDA, Health Canada, Europe, Australia/New Zealand, Japan, and Israel.
• Prepare accurate, timely responses to deficiency letters from regulatory agencies.
• Maintain life-cycle management and post-approval changes for drug product dossiers.
• Provide regulatory guidance to cross-functional internal departments.
• Prepare and submit scientific advice documentation to target health authorities.
• Manage eCTD compilation, verification, and submission via electronic gateways.
• Review, prepare, and submit Annual Reports and Post-Approval Supplements to the US FDA.

Skills

Regulatory affairs

Documentation review

Cross-functional collaboration

Education

B. Pharma / M. Pharma

Tools

eCTD submissions

US-FDA post-approval lifecycle management

Global dossier compilation

Job description

Executive / Senior Executive – Regulatory Affairs

Business Unit: Regulatory & Business Continuity
Job Grade: G12A / G11B
Location: Gurgaon, Haryana, India
Experience Required: 4–6 Years
Educational Qualification: B. Pharma / M. Pharma

About Sun Pharma: Create Your Own Sunshine

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.

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 while demonstrating a collaborative spirit to ensure we 'Thrive together'.

Key Responsibilities

• Review data and documentation for product registrations across global health authorities.
• Compile registration dossiers for submission to agencies including the US-FDA, Health Canada, Europe, Australia/New Zealand, Japan, and Israel.
• Prepare accurate, timely responses to deficiency letters received from regulatory agencies.
• Maintain life-cycle management and post-approval changes for drug product registration dossiers.
• Provide ongoing regulatory guidance and support to cross-functional internal departments.
• Prepare and submit scientific advice documentation to target health authorities.
• Manage eCTD compilation, verification, and submission via electronic gateway channels.
• Review, prepare, and submit Annual Reports and Post-Approval Supplements to the US FDA.

Job Requirements & Qualifications

• Education: Bachelor of Pharmacy (B. Pharma) or Master of Pharmacy (M. Pharma).
• Experience: 4 to 6 years of experience in Regulatory Affairs within the pharmaceutical industry.
• Skills: Expertise in eCTD submissions, US-FDA post-approval lifecycle management, and global dossier compilation.

Why Join Sun Pharma?

Your success and well-being are our top priorities. We provide robust benefits and competitive opportunities designed to foster both personal and professional growth. Join us at Sun Pharma to collaborate, innovate, and build a brighter future together.

Disclaimer: This job description outlines the general nature and level of work expected for this role. It is not an exhaustive list of all duties, responsibilities, and qualifications. Duties may be adjusted based on organizational needs and applicant experience.