Executive - Regulatory Affairs - EM Market

Sun Pharma · Gurgaon

  • Experience5–10 yrs
  • SalaryNot disclosed
  • Work modeonsite
  • Levelsenior
  • Posted18 Sept 2026
Apply for this job

About Sun Pharma

Sun Pharma is hiring in Gurgaon in pharma biotech. This role looks for around 5+ years of experience.

Skills

  • CMC dossiers
  • regulatory submissions
  • regulatory compliance
  • lifecycle management
  • drug formulation variations
  • quality dossiers
  • regulatory agency responses
  • change control

The role

A regulatory affairs executive at a pharmaceutical company prepares CMC dossiers, manages regulatory submissions and variations for drug formulations, and supports approvals across emerging markets. The role applies lifecycle management and regulatory compliance to maintain product approvals and information.

Full job description

Job Summary

Regulatory submission of new products, variations, response to queries, Life cycle management for WHO & Sub Sahara Africa markets through preparation of quality dossiers enabling timely approvals.

Area Of Responsibility

Area Of Responsibility

1. New submissions:

a. Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions.

b. Review documents (Development report, scale up report, specification, stability protocol), artworks etc.

before initiation of Exhibit batches for adequacy.

2. Approval:

Review & prepare response to deficiency enabling approval of products filed to regulatory agency.

3. Lifecycle management for drug formulations:

a. Prepare and review variations as per the country requirements to support approval of changes such as API

vendor changes/changes in ROS/test parameters; DF site changes; harmonization of products etc.

b. Prepare and review re-registration/PCH dossiers & submit the same to regional office/ regulatory agencies

4. Regulatory compliance:

a. Prepare, Review and circulate approval package to stake holders upon receipt of approval and update the

same based on queries and variations.

b. Ensure reposition of comprehensive product information into central repository

C. Review regulatory filing impact of variations, change controls, etc.