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Sr. Associate, Regulatory Operations

Cambridge, Massachusetts 02142

Post Date: 04/18/2018 Job ID: 1921 Job Category: Clinical: Regulatory

Our client is seeking a Sr. Associate, Regulatory Operations to be an integral part of the day to day publishing efforts, coordinating with internal team members and external vendors. Help to implement a content management system for the use of the entire company for authoring and approval of applications.

  • Electronically publish regulatory submission documents to industry and company defined standards (INDs, CTA, MAA, BLAs, eCTD, NeES, etc.)
  • Coordinate with vendors to support Regulatory submissions goals
  • Partner with regulatory team members as well as members of the Project Management, Commercial, Clinical, Medical Affairs, Clinical Operations, Nonclinical, CMC and Quality functions to ensure strong, clear communication and to identify and address challenging issues in the management of content for regulatory submissions. The primary focus will be on major marketing and clinical applications in order to achieve regulatory goals.
  • Electronically publish regulatory submissions using the eCTD software suite to industry and company defined standards
  • Adhere to assigned timelines for global regulatory submissions
  • Provide business user support for the workflow of regulatory submission documents through the document management system
  • Execute assigned activities for eCTD life-cycle document management within the document management system and the eCTD software suite
  • Execute and adhere to Regulatory Operations work practices and guidelines, as well as author new processes as required
  • Maintain the eCTD word processing templates and train users on their functionality

  • BA/BS degree and 2-5 years in the pharmaceutical industry Regulatory Operations arena is required
  • 2-5 years of hands on experience with an eCTD Software System is preferred
  • 2-5 years of advanced user skills using Microsoft Word and Adobe Acrobat desktop publishing techniques for regulatory submission documents are required
  • 2-5 year of user experience within an enterprise Document Management System is required
  • Knowledge of the industry standards for desktop publishing regulatory submission documents
  • Experience on a cross-disciplinary Regulatory Submission Team from the Regulatory Operations services perspective is desired
  • Experience with Microsoft Excel and Microsoft Project is desired
  • Ability to work effectively in a collaborative team environment where results are achieved through influence, cooperation, and the incorporation of multiple points of view
  • Independently motivated, detail oriented and good problem solving ability
  • Excellent organizational skills, with an ability to embrace change and multi-task in an extremely fast-paced environment
  • Excellent communications skills and ability to influence across multiple functions


Denise Kowalski
Clinical Recruiter

Denise is a focused, relationship-driven individual who brings creative energy and an eagerness to conquer new challenges to her role. A passionate life-long learner, Denise’s excellent communication skills, strong work ethic, and genuine interest in helping others make her a valuable asset to the Clinical team.

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