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

- 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

#LI-REMOTE

📌 Regulatory Affairs Consultant (India)
🏢 Parexel
📍 India