Job Description

Job Title: Regulatory Affairs – Executive / Sr. Executive

???? Location: Ahmedabad, Gujarat
???? Job Type: Full-time
???? Pay: ₹50,000 – ₹65,000 per month (CTC: ₹6–9 LPA)

???? Job Summary:

The primary responsibility of this role is to manage daily Regulatory Affairs operations and ensure timely submissions as per global regulatory timelines. This includes dossier preparation, query responses, lifecycle management, and compliance with regulatory authorities across EU, ROW, ZAZIBONA, and emerging markets.

???? Key Responsibilities:

• Manage and schedule activities across the Regulatory Affairs department.

• Compilation and review of Dossiers for:

  • ROW, ZAZIBONA, Emerging Markets

  • EU Markets: National, DCP, and MRP applications.

• Lifecycle management of products per EU and other international regulations.

• Develop and execute regulatory strategies for product submissions and CMC variations.

• Prepare CTD/ACTD dossiers and align filings with E2E product development strategies.

• Maintain regulatory databases and submission records.

• Coordinate with cross-functional teams: QC, QA, F&D, ADL, Manufacturing, Packaging, and CMO.

• Prepare and review SmPCs, PILs, Artworks, and regulatory applications.

• Ensure on-time and compliant submissions to regulatory authorities (FDA, CDSCO, international bodies).

• Compile and submit responses to regulatory queries and renewals.

• Manage Post Approval Submissions (PAS) and compliance documentation.

• Support inspections and ensure organizational regulatory readiness.

• Track renewals and regulatory deadlines.

• Stay updated on global regulatory changes and implement as required.

• Review product/process documentation for compliance and changes.

• Develop and interpret trial data for regulatory strategy.

• Support regulatory file maintenance and timely database updates.

• Handle any additional tasks as assigned by the department head.

???? Education & Qualifications:

• Master’s Degree in Pharmacy (any specialization) – Required

• BPharm/MPharm Certification – Preferred

???? Required Skills & Experience:

• Minimum 5 years in Regulatory Affairs, especially in Pharma.

• Minimum 4 years experience in EU submissions – Required

• Strong knowledge of regulatory requirements in:

  • EU, ZAZIBONA, ROW, Emerging Markets

  • ICH Guidelines

• Proficiency in dossier compilation, lifecycle management, and post-approval changes.

• Fluent in spoken and written English

• Detail-oriented, proactive, and collaborative team player with a strong learning mindset.

???? Contact:

Chitra – 9769460342

This opportunity is ideal for experienced professionals ready to lead and streamline regulatory processes in a globally-oriented pharmaceutical environment.

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