Regulatory Affairs Consultant

<p><b>When our values align, there&#39;s no limit to what we can achieve.</b><br /> <br />At Parexel, we all share the same goal - to improve the world&#39;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.</p><p>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&#39;re committed to making a difference.</p><p></p><p></p><ul><li>Around 7-10 years of relevant experience in handling life cycle management (LCM) of approved/marketed drug products (small molecules as well as biologicals including Vaccines, monoclonal antibodies) in various markets, mainly US and EU.</li><li>Good understanding of regulatory framework, including regional trends, for various types of applications and procedures.</li><li>Lead and / or contribute to the planning, preparation, authoring and delivery of regulatory maintenance submissions from either a global and/or regional perspective.</li><li>Working knowledge of EU/US regulatory procedures including post approval requirements. Knowledge of ROW markets regulatory legislations would be an added advantage</li><li>Experience in handling CMC related health authority queries, and author responses to HA requests</li><li>Preparation / Review of Regulatory gap analysis and strategy documents (with remediation plans for identified gaps) for submissions like IND, IMPD, DMF, BLA, NDA, and MAA applications.</li><li>Authoring and review of CMC component of Marketing Authorization Applications &amp; Variations for various types of medicinal products (orals &amp; parenteral) for filing in EU through different types of procedures (DCP/MRP/National Procedures).</li><li> Authoring CMC component for marketed products, of Annual Reports, Variations, Renewals in EU (Type IA/IB/II/IAIN), and US and RoW markets.</li></ul><ul><li>Evaluation of change controls and deviations and identification of required documentation and strategy for EU/US submissions and other markets.</li></ul><ul><li>Co-ordination with internal and external stakeholders for documentation required for various submissions. Identify quality and/or timeliness issues with source documents, as early as possible.</li><li>Develop up-to-date knowledge about regulatory guideline updates and applying regulatory requirements and their impact on submissions.</li><li>Working experience in Regulatory Information Management Systems (RIMS) like Veeva Vault.</li><li>Strong communications skills and ability to guide and mentor team members.</li><li>Ability to work independently.</li><li>Review and submit safety variations to Health Authorities and perform post Approval CMC / labeling related updates.</li><li>Authoring content of the drug product label (EU, Canada, AU/NZ &amp; US) based on Company Core Data Sheet (CCDS) / PRAC / CMDH recommendations.</li><li>Familiarity with EU Guidelines for QRD / Excipients.</li><li>Artwork management for countries with label in English.</li></ul>