Executive - Regulatory Affairs - EM Market

SUN PHARMA; Gurugram District; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

SUN PHARMA is seeking a Regulatory Affairs professional to manage submissions for new products and variations, handle queries, and oversee lifecycle activities to ensure timely approvals across markets. The role involves coordinating CMC dossiers, reviewing development and stability data, and maintaining comprehensive product documentation.

The candidate will prepare deficiency responses, harmonize information across regions, and work with cross-functional teams to ensure regulatory compliance

Responsibilities

• New submissions for regulatory filing.
• Review & prepare CMC dossiers for fresh submissions.
• Review documents (development report, scale up report, specification, stability protocol), artworks etc.
• Review & prepare response to deficiency enabling approval of products filed to regulatory agency.
• Lifecycle management for drug formulations: prepare and review variations per country requirements; include API vendor changes; harmonization of products.
• Regulatory compliance: prepare and review re-registration/PCH dossiers & submit to regional offices; circulate approval packages to stakeholders; update with queries and variations.

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

• New Submissions
• Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions.
• Review documents (Development report, scale up report, specification, stability protocol), artworks etc.

before initiation of Exhibit batches for adequacy.

Approval

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

Lifecycle management for drug formulations

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.

Regulatory compliance

Prepare and review re-registration/PCH dossiers & submit the same to regional office/ regulatory agencies. Prepare, Review and circulate approval package to stake holders upon receipt of approval and update same based on queries and variations.

• Ensure reposition of comprehensive product information into central repository
• Review regulatory filing impact of variations, change controls, etc.