Key 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
Desired Skills & Experience:
- Solid 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.
- 8 to 11 years of relevant experience
Educational Qualification:
- B.Sc. / M.Sc. / B. Pharmacy / M. Pharmacy