Senior Associate

<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><p>1 <b>Contribute to delivery of regulatory intelligence and pharmacovigilance (PV) regulatory intelligence for Mainland China and Taiwan.</b></p><ul><li>Deliver consolidated regulatory intelligence for Mainland China and Taiwan, in accordance with company expectations.</li></ul><p></p><p>2 <b>Regulatory/PV Regulatory Impact Assessment &amp; Stakeholder Engagement</b></p><ul><li>Monitoring and analysis of regulatory updates (including laws, guidelines, technical requirements, and trends) issued by the NMPA, CDE, TFDA and other relevant regulatory bodies in Mainland China and Taiwan</li><li>In conjunction with local GRAS SMEs, provide a local assessment/interpretation of new/revised regulatory information and triage for a global impact assessment according to company SOPs</li><li>Manage global impact assessments of new/revised regulatory information for Mainland China and Taiwan according to company SOPs</li><li>In conjunction with local PV SMEs, provide a local assessment/interpretation of new/revised PV regulatory intelligence and triage for a global impact assessment according to company SOP.</li></ul><p></p><p>3 <b>Regulatory Policy: Intelligence Analysis &amp; Support</b></p><ul><li>Provide intelligence analyses and support for regulatory policy priorities (e.g., major legislative changes with direct impact on CSL).<ul><li>Track regulatory policy updates trends issued by the NMPA, CDE, and other relevant regulatory bodies in Mainland China and Taiwan.</li><li>Provide strategic input to company SMEs by curating impact assessments, including evaluating potential impacts on technical and procedural requirements and translating these into actionable insights.</li><li>Support policy activities by providing preliminary analysis of regulatory challenges and opportunities and insights on how to mitigate risks or capitalise on opportunities</li><li>Provide analyses according to company processes and using company templates.</li></ul></li></ul><p>Maintain structured regulatory intelligence tracking to ensure timely awareness of emerging regulatory signals.</p><p></p><p>4 <b>Global-Local Regulatory Alignment &amp; Liaison </b></p><ul><li>Liaise with local and global GRAS teams/SMEs, clinical, medical affairs, and quality assurance SMEs to ensure alignment on impact assessment activities.</li><li>Advise internal regulatory teams and GRASP Regional Lead on evolving regulatory expectations.</li><li>Ensure alignment between country-specific regulatory intelligence and the company’s global regulatory intelligence/impact assessment framework.</li></ul><p></p><p>5 <b>Regulatory Intelligence Infrastructure Management</b></p><ul><li>Develop, maintain, and optimize regulatory intelligence databases, trackers, and internal communication channels.</li><li>Ensure all regulatory intelligence activities adhere to the company’s internal governance policies and compliance standards.</li><li>Support the preparation and conduct of PV inspections and audits, as requested.</li></ul><p></p><p></p>