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. Senior Regulatory Affairs Associate -Biologics Relevant experience in handling the life-cycle management of approved drug products, including small molecules and biologics (vaccines and monoclonal antibodies), across various global markets. Good understanding of the regulatory framework, including regional trends, for different types of applications and procedures. Contribute to the preparation (including authoring, where relevant) and delivery of simple regulatory maintenance submissions and, with experience, increasingly complex submissions from a global and/or regional perspective. Working knowledge of EU and US regulatory procedures, including post-approval requirements. Knowledge of regulatory legislation in Rest of World (ROW) markets would be an added advantage. Experience in handling CMC-related Health Authority (HA) queries and authoring responses to HA requests. Strong understanding of regulatory frameworks, including regional trends, for various application types and procedures related to both small and large molecules across global markets, as well as knowledge of global pharmaceutical legislation and guidance, particularly regulatory CMC aspects within ICH countries. Experience in authoring and reviewing the CMC components of Marketing Authorization Applications (MAAs) and Variations for different types of medicinal products (oral and parenteral) filed in the EU through DCP, MRP, and National Procedures. Preparation