Senior Regulatory Affairs Associate

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 Senior Associate must have an understanding of the organization’s basic consulting models and methodologies, as well as basic knowledge of what services PC provides. A Senior Associate must be technically competent and continually developing the skills as defined in the key accountabilities section of this document. A Senior Associate, under the general direction of a Project Lead and/or Technical SME, takes responsibility for ensuring that client work is performed, and delivered on time, meeting the quality expectations of PC and the client. A Senior Associate may act in a client facing role with support from line management. When serving as a Project Lead or Work Stream Lead, a Senior Associate 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.

• 5 to 8 years of relevant experience

Educational Qualification

• B.Sc. / M.Sc. / B. Pharmacy / M. Pharmacy