Regulatory Strategist

<p>The Regulatory Strategist - China will work closely with sponsor companies in developing regulatory strategies that will support drug development initiatives in China. This responsibility will include leading client interactions with the NMPA. This position will also work as an internal consultant/advisor across various Labcorp business units to facilitate dialogues with our clients to develop relevant regulatory strategy and tactic plans to meet their drug development needs.</p><p></p><p><br />Key responsibilities:</p><ul><li>Collaborate closely with internal Labcorp project teams in the design and development of regulatory strategies in China for client projects or to answer client inquiries.</li><li>Collaborate with the Strategic Product Development Consulting group in providing support and input for one another’s projects based on past therapeutic experience and local regulatory expertise.</li><li>Maintain knowledge of the current regulatory environment by reviewing and communicating current policies/practices issued by NMPA. </li><li>Interact and collaborate with all Labcorp business unit personnel</li><li>Establish productive working relationship and collaborate closely with Regulatory Submissions staff.</li><li>Create and build confidence by representing the regulatory strategy function as an informed, capable, knowledgeable, responsible and accessible resource to Labcorp staff, management and clients, positioning Labcorp as a preferred source for regulatory strategy expertise.</li><li>Build successful working relationships with business and scientific leaders across Labcorp.</li><li>Provide regulatory affairs expertise and support to the business development group in presentations to Pharma/biotech customers when requested.</li></ul><p></p><p>Position Requirements:</p><ul><li>At least 10 years’ experience of drug development in the Pharma, biotech or CRO industry with at least 6-7 years’ experience in regulatory affairs developing regulatory strategies for early and late stage development programs.</li><li>PharmD, MD or PhD in a life science, pharmacy or medicine is preferred.</li><li>Experience in clinical research, discovery research, preclinical pharmacology, or toxicology preferred.</li></ul><p></p><p><b>Labcorp is proud to be an Equal Opportunity Employer:</b></p><p></p><p>As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.</p><p></p><p>For <span>more information about how we collect and store your personal data, please see our </span><span><a href="https://www.labcorp.com/hipaa-privacy/web-privacy-policy" target="_blank">Privacy Statement</a></span><a href="https://www.labcorp.com/hipaa-privacy/web-privacy-policy" target="_blank"><span>.</span></a><span> </span></p>