Executive - EM RA

SupportFinity™; Vadodara; On-site; INR 400,000 - 600,000; Full time

Job summary

SupportFinity™ in Vadodara seeks an Executive – Regulatory Affairs to manage regulatory submissions, renewals, and lifecycle for products in MENA markets. Candidates with 1-4 years of experience and a background in M.Sc/M.Pharm will be preferred.

This role includes reviewing documentation, preparing regulatory compliance packages, and ensuring timely approvals. Knowledge of product information management is crucial.

Qualifications

• 1-4 years of experience in Regulatory Affairs.
• Strong knowledge of regulatory submissions and lifecycle management.

Responsibilities

• Review & prepare CMC dossiers for submissions.
• Prepare responses to deficiencies from regulatory agencies.
• Manage lifecycle changes for drug formulations.
• Ensure compliance with regulatory requirements.

Education

Graduate — M.Sc / M.Pharm

Job description

Job Details

Job Title: Executive – Regulatory Affairs

Business Unit: R&D1 Regulatory Affairs

Job Grade: G12A

Location: Baroda

Job Description

Regulatory submission of new products, renewals, variations, response to queries and life cycle management for MENA markets through preparation of quality dossiers enabling timely approvals.

Responsibilities

• New submissions/renewals: 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 responses to deficiencies enabling approval of products filed to regulatory agency.
• Lifecycle management for drug formulations: Prepare and review variations as per country-specific 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, review and circulate approval packages with product history sheets to stakeholders upon receipt of approval and update them based on queries and variations.
• Ensure repositioning of comprehensive product information into a central repository.
• Review regulatory filing impact of variations, change controls, etc.

Geographic Scope

South Africa, Middle East, GCC

Travel

NA

Qualifications

• Educational Qualification: Graduate — M.Sc / M.Pharm
• Experience: Tenure: 1-4 years