Regulatory Affairs Consultant

This is a fully remote position, open to applicants in India.

📋 Description

• Assist in managing global regulatory lifecycle activities across EU, US, and international markets.

• Play a role in the development of regulatory strategies for both global and regional submissions.

• Prepare, coordinate, and deliver regulatory submission packages (Modules 1–5).

• Oversee post-approval changes, variation submissions, and associated follow-up activities.

• Address Health Authority inquiries and ensure prompt responses.

• Provide support for submission management, including planning, coordination, and timeline monitoring.

• Keep accurate records in Regulatory Information Management (RIM) systems.

• Assist with safety-related regulatory tasks such as aggregate reports and urgent safety updates.

• Support audit, compliance, and inspection readiness efforts.

⛳️ Requirements

• 8 to 11 years of pertinent experience.

• In-depth knowledge of EU & US regulatory processes and post-approval obligations.

• Proven experience in global submission management and lifecycle maintenance.

• Familiarity with regulatory documentation and compliance standards.

• Excellent coordination and stakeholder management abilities.

• B.Sc. / M.Sc. / B. Pharmacy / M. Pharmacy degree.

🏝️ Benefits

• Health insurance.

• Flexible work arrangements.

• Opportunities for professional development.