Senior Regulatory Affairs Associate

Job description

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