Regulatory Affairs Associate

Job Description:

Responsibilities

•  Support global regulatory lifecycle management activities across EU, US, and international markets
•  Contribute to regulatory strategy development for global and regional submissions
•  Prepare, coordinate, and deliver regulatory submission packages (Modules 1–5)
•  Manage post-approval changes, variation submissions, and follow-up activities
•  Handle Health Authority queries and ensure timely responses
•  Provide submission management support including planning, coordination, and timeline tracking
•  Maintain accurate records in Regulatory Information Management (RIM) systems
•  Support safety-related regulatory activities such as aggregate reports and urgent safety updates
•  Assist with audit, compliance, and inspection readiness activities

Qualification & Experience

•  Strong knowledge of EU & US regulatory procedures and post-approval requirements
•  Experience in global submission management and lifecycle maintenance
•  Understanding of regulatory documentation and compliance standards
•  Strong coordination and stakeholder management skills.
•  2 to 4 years of relevant experience
• Educational Qualification
•  B.Sc. / M.Sc. / B. Pharmacy / M. Pharmacy