Executive - IRA

Sun Pharma; Vadodara; On-site; INR 800,000 - 1,100,000; Full time

Job summary

Sun Pharmaceutical Industries Ltd is seeking an Executive – Regulatory Affairs to support regulatory submissions and dossier preparation for CDSCO approvals in India. The role involves evaluating regulatory strategies, reviewing CMC documents, coordinating cross-functional inputs, and preparing regulatory letters and submissions.

Position requires M.Pharm and 2–5 years of relevant experience. Based in Vadodara, Gujarat, the incumbent will coordinate with multiple teams to ensure timely approvals

Qualifications

• Regulatory affairs professional with knowledge of India's CDSCO processes.
• Experience in dossier compilation and regulatory submissions is preferred.
• Strong coordination with cross-functional teams and attention to detail.

Responsibilities

• Evaluate regulatory strategies for products to be registered in India.
• Review CMC and other documents; coordinate with cross-functional teams for corrections.
• Prepare cover letters and regulatory documents; compile regulatory dossiers for CDSCO submissions.
• Obtain CT, BE, and domestic manufacturing/marketing permissions.
• Coordinate IPC testing dossier; ensure sample readiness and submission.
• Manage post-approval changes and Phase IV CT applications.
• Check product label artwork and coordinate corrections.
• Prepare prescribing information.

Skills

Regulatory affairs

Documentation

Cross-functional coordination

Education

M.Pharm

Job description

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Company: Sun Pharmaceutical Industries Ltd

Job Title:

Executive – Regulatory Affairs

Business Unit:

R&D1 Regulatory Affairs

Job Grade

Location:

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.”

Job Summary

Evaluation of regulatory documents, compilation of dossier and submissions to CDSCO-HQ for regulatory approval of drug substance and drug products.

Area of responsibility:

• Evaluation of regulatory strategies for products to be registered in India
• Review of CMC & other documents, coordination with cross functional teams for necessary corrections, preparation of cover letter of application & other regulatory documents, compilation of regulatory dossier and submission on the portal of regulatory authority for obtaining,
  • CT, BE and domestic manufacturing and marketing permission
  • Import & marketing approval in India
  • Compilation of IPC testing dossier and coordination for sample readiness and submission to laboratory
  • Post approval changes
  • Phase IV CT applications
  • Additional site notification/approval
  • Condition compliance
• Checking artworks of product label and coordinate for necessary corrections

Preparation of prescribing information

NA

Job Requirements

Educational Qualification

M.Pharm

Experience

Minimum 2-5 years of relevant experience

Your Success Matters to Us

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).