Shire Regulatory Tech & IM Manager in Cambridge, Massachusetts
Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification has been filed by Shire Human Genetic Therapies Inc. for the following job opportunity:
JOB LOCATION: Cambridge, MA
POSITION : Regulatory Tech & IM Manager
POSITION DESCRIPTION: Shire 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 Shire careers page at: https://jobs.shire.com. Please reference job #R0029182. EOE
Any 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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Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.