Regulatory Affairs Consultant

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