US-MA, Regulatory Product License Support Manager SR0031420-MZ
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, MA POSITION: Regulatory Product License Support Manager POSITION DESCRIPTION: Takeda Human Genetic Therapies Inc. is seeking a Regulatory Product License Support Manager with the following duties: develop submission model for outsourcing of US Advertising and Promotional (Ad Promo) submission and developing process and ensuring continuous process improvement of established model; manage relationship and transfer of work between Takeda and third parties for planning, publishing and review and dispatch of Ad Promo regulatory compliance submissions including compliance with agreed upon metrics and ensuring timely submission of high quality, compliant and valid submissions to global health authorities within required timeframes; collaborate with GRO submission teams to have oversight to and ensure the submission portfolio is properly supported with an emphasis on US Ad Promo submission, with in-house publishing team; work with internal and external stakeholders to ensure business needs are met; stay current with new electronic submission and regulatory documentation practices issued from global health authorities; propose new regional and global processes for paper and electronic submission publishing, including the evaluation of current processes; provide Subject Matter Expertise for technical publishing tools and provide efficiency/enhancement proposals for the publishing tool suites; contribute to new and updated processes and standards; participate in validation testing of new and upgraded software; ensure accuracy of information for submission metrics and registration information for senior management; participate in GRA special initiatives; work with outsourcing publishing partners for FDA Submissions; utilize knowledge of eCTD Publishing Suite and Document Management systems; perform UAT testing and implement publishing and document management systems; utilize Project Management experience in a global regulatory submission environment as well as experience submitting to Global Health Authorities, including, EMEA, Australia, Canada and India. REQUIREMENTS: Bachelor s degree in Science; Regulatory Affairs for Drugs, Biologics and Medical Devices; or related degree plus 5 years related experience. Will accept any level of experience in the following required skills: work with outsourcing publishing partners for FDA Submissions; utilize knowledge of eCTD Publishing Suite and Document Management systems; perform UAT testing and implement publishing and document management systems; utilize Project Management experience in a global regulatory submission environment as well as experience submitting to Global Health Authorities, including, EMEA, Australia, Canada and India. Full time. $163,800.00- $180,180.00/year. Competitive compensation and benefits. Qualified applicants can apply directly to the Takeda careers page at: https://jobs.Takeda.com. Please reference job #R0031420. 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.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
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