Regulatory Affairs Consultant

Job description

A Consultant must have an understanding of the organization’s consulting models and methodologies, as well as, good knowledge of what services PC provides. A consultant must have strong technical skills and may be developing specialist knowledge of a particular subject and/ or market. A Consultant ensures the timely performance of work within a project scope to the quality expectations of PC and the client. When serving as a Project Lead or Work Stream Lead, a Consultant assures the work of the entire team or work stream is delivered on time and that it meets client’s and PC’s quality expectations. **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** - 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. - 8 to 11 years of relevant experience **Educational Qualification** - B.Sc. / M.Sc. / B. Pharmacy / M. Pharmacy