Regulatory Affairs Executive

4 days ago

Borivli, Maharashtra, India Alvita Pharma Pvt. Full time ₹ 1,80,000 - ₹ 3,60,000 per year

Job Description:

Regulatory Affairs – Dossier Preparation & Lifecycle Management

Key Responsibilities:

Dossier Preparation & Review:

Prepare, compile, and critically review regulatory dossiers (CTD/eCTD format) for submission in compliance with country-specific regulatory guidelines.

Ensure completeness, accuracy, and quality of all submission documents.

Query Management:

Handle and respond to regulatory queries in a timely and efficient manner.

Coordinate with cross-functional teams to gather required clarifications and documentation.

Lifecycle & Project Management:

Manage the end-to-end lifecycle of product registrations including new submissions, renewals, and variations.

Track project timelines, regulatory milestones, and ensure on-time delivery of submissions.

Regulatory Intelligence & Guideline Updates:

Regularly monitor and interpret updates in country-specific regulatory guidelines.

Ensure internal processes and documentation are aligned with the latest regulatory expectations.

Cross-Functional & External Coordination:

Liaise with third-party manufacturers to gather technical documents and compliance-related data.

Collaborate with internal departments such as QA, QC, R&D, and Supply Chain for seamless documentation and query resolution.

Countries of Regulatory Responsibility:

  • Nigeria
  • Zimbabwe
  • Ukraine
  • French West Africa (FWA) – Additional updates applicable

Job Type: Full-time

Pay: ₹15, ₹30,000.00 per month

Benefits:

  • Leave encashment
  • Provident Fund

Work Location: In person

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