Regulatory Affairs Associate

An Associate must have a knowledge of the organization’s basic consulting models and methodologies as well as basic knowledge of what services PC provides. An Associate must be technically competent and continually developing the skills as defined in the key accountabilities section of this document. An 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. The guidance of more senior staff may be needed to accomplish more complex tasks. An Associate may act in a client facing role with clear guidance and support from line management. 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 2 to 4 years of relevant experience Educational Qualification B.Sc. / M.Sc. / B. Pharmacy / M. Pharmacy 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. #J-18808-Ljbffr