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Manager, Regulatory Operations

Cambridge, Massachusetts 02142

Post Date: 05/15/2018 Job ID: 1816 Job Category: Clinical: Regulatory

The successful candidate will be responsible for the maintenance and support of Regulatory systems used to facilitate the creation of compliant submissions and for the maintenance of Regulatory information. They will also support the compilation, archiving, and tracking of regulatory submissions and correspondence interfacing with Regulatory technology and publishing partners.

Job  Responsibilities:
  • Maintain and support Regulatory systems such as electronic document management (EDMS), Regulatory Information Management (RIM), and eCTD publishing
  • Manage and oversee the development of training materials specific to Regulatory systems
  • Liaise with internal and external stakeholders to ensure the compliance of deliverables being transmitted to a health authority
  • Represent Regulatory Operations on internal teams to support filing activities
  • Prepare and transmit electronic submissions (paper submissions, when applicable)
  • Interface with external publishing partners on submission compilation


Qualifications/ Requirements: 
  • 5-7 years’ experience working in a Regulatory Operations environment
  • Detailed knowledge of eCTD publishing systems, EDMS technology, and publishing software
  • Experience managing EDMS, regulatory publishing systems, and tracking databases
  • Detailed knowledge of clinical and nonclinical data standards (ADaM, SDTM, SEND)
  • Expert knowledge of Microsoft Office and Adobe Suite (MS Project is a plus)
  • Demonstrated experience and a clear understanding of submission content and format requirements
  • The ability to multitask, prioritize, and work under pressure in adhering to deadlines
  • Solid experience administering and maintaining Regulatory document authoring templates
  • Strong oral and written communication and interpersonal skills
  • Strong project management and organizational skills

Aaron Goldman
Clinical Recruiter

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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