Executive/Sr.Executive

Sun Pharma; Gurugram District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Sun Pharma in Gurgaon is seeking an Exe / Sr. Exe in Regulatory & Business Continuity to oversee product registrations with global health authorities. The role emphasizes data review, dossier preparation, and cross-functional regulatory support.

The candidate will handle submissions to US FDA, Health Canada, Europe, Australia/New Zealand, Japan, and Israel, respond to deficiency letters, and manage post-approval changes to ensure continued compliance.

Qualifications

• B. Pharma / M. Pharma degree required.
• Tenure: 4-6 years in regulatory affairs or related area.
• Experience reviewing product registrations for health authorities.
• Prepare and submit registration dossiers to US FDA, Health Canada, Europe, Australia/New Zealand, Japan and Israel.

Responsibilities

• Review data and documents related to product registrations for health authorities.
• Compile registration dossiers for submission to US FDA, Health Canada, Europe, Australia/New Zealand, Japan and Israel.
• Prepare responses to deficiency letters from various agencies.
• Maintain life-cycle / post-approval changes for drug product registration dossiers.
• Provide regulatory support to cross-functional departments.
• Prepare and submit scientific advice to 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.

Education

B. Pharma / M. Pharma

Job description

Job Title:

Exe / Sr. Exe

Business Unit:

Regulatory & Business Continuity

Job Grade

G12A /G11B

Location:

Gurgaon

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.”

Key Responsibilities

• 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.
• Maintain life‑cycle / post approval changes for drug product registration dossiers.
• 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

Job Requirements

Educational Qualification –

B. Pharma / M. Pharma

Experience –

Tenure: 4‑6 Years

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).