publishing | Regulatory Tech & IM Manager in Cambridge, MA

Regulatory Tech & IM Manager

  • Takeda Pharmaceuticals
  • 6 Dunstable Rd
  • Cambridge, MA 02138
  • Full-Time
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Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification has been filed by Takeda Human Genetic Therapies Inc. for the following job opportunity:JOB LOCATION: Cambridge, MAPOSITION: Regulatory Tech & IM ManagerPOSITION DESCRIPTION: Takeda Human Genetic Therapies Inc. is seeking a Regulatory Tech & IM Manager with the following duties: provide technical and business support to the Global R&D users that are using the Global Regulatory Systems and Applications; ensure that GRA requirements are incorporated and supported by both new systems and also upgraded to existing systems, in partnership with R&D IT; provide recommendations in formulating new technology and guidance; Provide Business User support and recommendations on the structure and preparation of electronic regulatory specifications and submissions and the ability of publishing tools and systems to support them; represent Global Regulatory Affairs (GRA) as a Subject Matter Expert, providing both business and technical solutions for GRA systems, developing and maintaining supporting information related to the use of GRA systems, e.g. system job aid/ help guide; collaborate with the respective R&D Information Technology teams to drive the development and update of Global Regulatory requirements, processes and standards; establish, update and implement Regulatory required formats, templates, policies, standards, and procedures for regulatory submissions; maintain up-to-date knowledge of global standards and procedures for regulatory submissions, including eCTD, IDMP; publish standards and analyze new and revised guidance, advice regulatory management of new requirements, and recommend course of action; provide recommendations on the approach for the application of expert knowledge of global regulatory; ensure budgets, schedules and performance requirements are met; act as subject matter expert (SME) for GRA System; provide technical and business support for R&D systems; manage support, troubleshooting and communicate with business; act as key contact from IT for business; identify solutions for critical business needs; perform process development methodologies specific to Pharma and validated systems.REQUIREMENTS: Bachelor's degree in Engineering, Computer Science or related field plus 6 years related experience. Will accept any level of experience in the following required skills: act as subject matter expert (SME) for GRA System; provide technical and business support for R&D systems; manage support, troubleshooting and communicate with business; act as key contact from IT for business; identify solutions for critical business needs; perform process development methodologies specific to Pharma and validated systems.Full time. $108,000.00 - $146,000.00/year. Competitive compensation and benefits.Qualified applicants can apply directly to the Takeda careers page at: Please reference job #R. EOEAny individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Foreign Labor Certification National Processing Center, Harris Tower, 233 Peachtree Street, Suite 410, Atlanta, GA 30303.

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