Executive - IRA

SUN PHARMA; Madhya Pradesh; On-site; INR 600,000 - 900,000; Full time

Job summary

Sun Pharma in Vadodara is seeking an Executive – Regulatory Affairs to evaluate regulatory documents, compile dossiers, and submit to CDSCO for drug substance and drug products. The role requires preparing regulatory submissions, coordinating with cross-functional teams, and ensuring compliance throughout the submission process.

The candidate should have M.Pharm with 2–5 years of relevant regulatory experience, and will work closely with manufacturing, quality, and clinical teams to drive

Qualifications

• Experience in regulatory submissions and dossiers in India is preferred.
• Strong attention to detail and documentation quality.
• Ability to coordinate across clinical, manufacturing and quality teams.

Responsibilities

• Evaluate regulatory strategies for products to be registered in India.
• Review CMC and other regulatory documents; coordinate with cross-functional teams for corrections; prepare cover letters and regulatory dossiers; submissions on the CDSCO portal.
• Handle post-approval changes and Phase IV CT applications; coordinate IPC testing dossiers and sample readiness.
• Check artworks of product labels and coordinate necessary corrections; prepare prescribing information.

Skills

Regulatory affairs

Documentation

Cross-functional coordination

Education

M.Pharm

Job description

Job Description

Executive – Regulatory Affairs

Business Unit

R&D1 Regulatory Affairs

Job Grade

G12A

Location

Vadodara

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

Travel Estimate

NA

Job Requirements

Educational Qualification

M.Pharm

Experience

Minimum 2-5 years of relevant 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!