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Regulatory Assoc Mgr

Laboratory Corporation of America Holdings (Covance)

Tokyo, Japan

<h2>Job Overview:</h2><p style="margin: 0px;"><strong><span style="font-family: 'Times New Roman',serif; color: windowtext;">Job Summary:</span></strong></p><p style="margin-top: 0mm;"><span style="font-family: 'Times New Roman',serif; color: windowtext;">Works directly with GRA Leadership, GRA personnel, as well as PMO and Finance in leading the </span><span style="font-family: 'Times New Roman',serif; color: windowtext;">project review process, raising issues for resolution, ensuring action items are completed, and </span><span style="font-family: 'Times New Roman',serif; color: windowtext;">communicating the health of both project and the portfolio to GRA Leadership. Candidate will </span><span style="font-family: 'Times New Roman',serif; color: windowtext;">work with key leaders to manage the overall performance of the portfolio by interpreting metric </span><span style="font-family: 'Times New Roman',serif; color: windowtext;">and project review information resulting in actionable plans to improve delivery efficiencies to our </span><span style="font-family: 'Times New Roman',serif; color: windowtext;">clients. Candidate will assume responsibility for GRA business development activities intended to </span><span style="font-family: 'Times New Roman',serif; color: windowtext;">increase business for regulatory services. Additional responsibilities include leading cross-project </span><span style="font-family: 'Times New Roman',serif; color: windowtext;">and financial processes improvements, mentoring teams on improving project performance and </span><span style="font-family: 'Times New Roman',serif; color: windowtext;">taking on special projects as deemed appropriate by GRA Leadership.</span></p><p style="margin-top: 0mm;"><span style="font-family: 'Times New Roman',serif; color: windowtext;">Regulatory PM Associate (RegPMa) provide extensive support to develop client’s products, multiple projects at a time, regularly interact and communicate with client staff (including senior client staff) as the client’s main point of contact, and must work to high standards with minimal supervision. RegPMa work with a variety of global clients, generally virtual or small</span> <span style="font-family: 'Times New Roman',serif; color: windowtext;">to mid-sized companies, across all asset types (drug, biologic, cell/gene therapy), and across all therapeutic areas.</span></p><p style="margin-top: 0mm;"> </p><p style="margin: 0px;"><strong><span style="font-family: 'Times New Roman',serif; color: windowtext;">Essential Job Duties: </span></strong></p><ul><li><span style="font-family: 'Times New Roman',serif; color: windowtext;">Manage multi-functional regulatory projects. Participate in cross-functional initiatives.</span></li><li><span style="font-family: 'Times New Roman',serif; color: windowtext;">Involvement in leading proposal and bid defense efforts for regulatory projects where more than one Regulatory function is included. </span></li><li><span style="font-family: 'Times New Roman',serif; color: windowtext;">Lead Product Development Team, which is a multidisciplinary team, across the entire enterprise for the client’s relationship, localization, the drug development goal, etc.</span></li><li><span style="font-family: 'Times New Roman',serif; color: windowtext;">Contribute to GRA materials for proposal templates, Account Executive training, and GRA capabilities content.</span></li><li><span style="font-family: 'Times New Roman',serif; color: windowtext;">Identify, promote and implement best practices for GRA driving for sustainable competitive advantage.</span></li><li><span style="font-family: 'Times New Roman',serif; color: windowtext;">Work with CTMO and GRA Leadership to: Recommend areas of improvement across clients to enhance operational performance, Lead improvement processes and ensure implementation throughout the organization. </span></li><li><span style="font-family: 'Times New Roman',serif; color: windowtext;">Participate in and/or lead business development activities to increase business for regulatory services and enterprise molecule development work.</span></li><li><span style="font-family: 'Times New Roman',serif; color: windowtext;">Perform other duties as assigned by GRA Leadership.</span></li></ul><h2>Education/Qualifications:</h2><p style="margin-top: 0mm;"><strong><span style="font-family: 'Times New Roman',serif; color: windowtext;">Recommended:</span></strong></p><p style="margin-top: 0mm;"><span style="font-family: 'Times New Roman',serif; color: windowtext;">Master’s Degree in Life Sciences or equivalent </span></p><h2>Experience:</h2><p style="margin-top: 0mm;"><strong><span style="font-family: 'Times New Roman',serif; color: windowtext;"> </span></strong></p><p style="margin-top: 0mm;"><strong><span style="font-family: 'Times New Roman',serif; color: windowtext;">Minimum Required: </span></strong></p><p style="margin-top: 0mm;"><span style="font-family: 'Times New Roman',serif; color: windowtext;">Minimum of 5 years’ experiences in the Pharmaceutical industry in Regulatory Affairs or Drug </span><span style="font-family: 'Times New Roman',serif; color: windowtext;">Development</span><span style="font-family: '游明朝',serif; color: windowtext;">,</span> <span style="font-family: 'Times New Roman',serif; color: windowtext;">Medical device development</span><span style="font-family: '游明朝',serif; color: windowtext;">,</span> <span style="font-family: '游明朝',serif; color: windowtext;">Diagnostic drug development</span></p>

Job posted: 2021-11-17

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