When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will advantage a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
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
Robust coordination and stakeholder management skills.
8 to 11 years of relevant experience
Educational Qualification
B.Sc. / M.Sc. / B. Pharmacy / M. Pharmacy
📌 Regulatory Affairs Consultant Hyderabad (India)
🏢 Parexel
📍 India