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 - Solid coordination and stakeholder management skills. - 5 to 8 years of relevant experience **Educational Qualification** - B.Sc. / M.Sc. / B. Pharmacy / M. Pharmacy #LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

📌 Senior Regulatory Affairs Associate (India)
🏢 Parexel
📍 India