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Regulatory Operations Manager
Ref No.: 18-12023
Location: Cambridge, Massachusetts
Start Date: 09/18/2018
The Role:

The Regulatory Operations Manager is responsible for all operational aspects involved in the preparation and maintenance of regulatory submission documentation. This includes formatting assistance, assembly, and archival of paper and electronic submissions and submission components according to quality standards and defined timelines. Also, responsible for other tasks as assigned.


Here's What You'll Do:
  • Assist in compiling regulatory submissions for assigned submissions. Coordinate distribution of submissions to all concerned parties (HA, CRO) within agreed upon timeframes. Manage submission and product life-cycle information.
  • Ensure completion of high-quality submissions, following regulatory guidelines and internal processes within time lines.
  • Organize and maintain submission components associated with a regulatory submission, paper and/or electronic, as required. This may include, but is not exclusive to, setting up templates and Binder templates, scanning, printing, and indexing.
  • Responsible for all operational tasks associated with or in support of authoring (formatting, editing, reviewing), publishing (non-outsourced projects), production (paper and electronic), and archiving (paper and electronic), as applicable.
  • Create, update and maintain submission templates that meet global regulatory requirements
  • Coordinate the receipt and archival of regulatory files (correspondence) transmitted from/to HAs.
  • Maintain familiarity with current regulatory submission standards, software validation concepts, and publishing best practices.
  • May participate in the development and implementation of regulatory operational systems and software (e.g. document management systems, databases, forecasting tools, etc.)
  • Perform administrative functions as directed by Management.
  • Support regulatory documentation users and contributors.
  • Act as interface with external publishing partners


Here's What You'll Bring to the Table:
  • Bachelors degree in a scientific discipline or systems technology or equivalent
  • 5-8 years of pharmaceutical experience working in a regulated, life science
environment (pharmaceutical, biotechnology, consumer health)
  • Advanced working knowledge of eCTD publishing systems, EDMS technology, and
related publishing tools
  • Extensive knowledge of North American/Global submission standards (FDA, Health
  • Canada, EMA, ICH, eCTD, etc.) and industry trends for dossier preparation (INDs,
CTAs, etc.)
  • Knowledge of CDISC (ADaM, SEND, SDTM)
  • A demonstrated ability to lead and/or collaborate with groups cross-functionally (Regulatory, clinical, nonclinical, etc.)
  • Excellent document formatting/troubleshooting skills in MS Word/PDF Professional.
  • MS PowerPoint skills