Executive Sr Executive

SUN PHARMA; Gurugram District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Sun Pharma is seeking an Exe / Sr. Exe in Regulatory & Business Continuity based in Gurgaon. The role focuses on handling product registrations and life-cycle activities across multiple health authorities.

The ideal candidate holds a B. Pharma or M. Pharma with 4-6 years of regulatory experience, including eCTD submissions and deficiency responses. Join us to contribute to global regulatory excellence and grow with the Sun Pharma team.

Qualifications

• B. Pharma or M. Pharma required.
• Experience in regulatory submissions and lifecycle management.
• Familiarity with US FDA, Health Canada, Europe, Australia, Japan, Israel workflows.

Responsibilities

• Review data and documents for product registrations across health authorities.
• Prepare registration dossiers for authorities like US FDA, Health Canada, Europe, Australia, Japan, Israel.
• Prepare deficiency responses from agencies.
• Maintain lifecycle / post-approval changes for dossiers.
• Provide regulatory support to cross-functional teams.
• Prepare and submit scientific advice to health authorities.
• eCTD compilation and submission via electronic gateway.
• Review and submit annual reports to US FDA.
• Review and submit post-approval supplements to US FDA.

Skills

Regulatory knowledge

Documentation

eCTD submissions

Cross functional

Education

B. Pharma / M. Pharma

Job description

Job Description

Job Title

Exe / Sr. Exe

Business Unit

Regulatory & Business Continuity

Job Grade

G12A /G11B

Location:

Gurgaon

Are You Ready to 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. 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

Requirements

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).