Regulatory Affairs Consultant

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 benefit 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

- 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

Originally posted on Himalayas