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Regulatory Affairs Manager

2 months ago

Princeton, United States SYSTEM EDGE (USA) L.L.C. Full time

Position: Regulatory Affairs Manager

Location: Princeton NJ – Remote


Job Description:


The task includes supporting necessary submission activities for CTAs under the EU CTR.

Essential Duties and Responsibilities:

  • Prepare and submit CTAs within the EU Clinical Trial Integrated System (CTIS) and MHRA Integrated Regulatory Submission (IRAS) submission portals in accordance with regulatory requirements, using Submission Management tools and an EDMS system.
  • Perform independent QC on prepared CTA submissions which include submission documents and structured data populated within the HA submission portals.
  • Monitor the submission portals during designated working hours for notices and alerts from the HAs and provide these communications to appropriate FAs in accordance with timelines and processes.
  • Maintain oversight of Otsuka functional area user management for CTA required systems and tools.
  • Act as a liaison while coordinating CTA activities with other multidisciplinary teams.
  • Provide expertise on CTIS and IRAS portals to appropriate FAs as required during preparation and submittal of CTA submissions.
  • Provide support for preparation, submission, lifecycle, and archival of CTA submissions and correspondences.
  • Assist with development of assigned regulatory operations work instructions.
  • Perform User Acceptance Testing (UAT) for submission management tools, as required.
  • Participate in new technology evaluation for Regulatory Operation’s needs.
  • Stay abreast with updates for regulatory and/or industry standards.

Required Competencies:

  • Overall knowledge of regulation/guidance in support of EU Clinical Trial Regulation (CTR) and UK The Medicines for Human Use (CTs) (Amendment) (EU Exit) Regulations 2019.
  • Demonstrated performance in managing and producing time-intensive deliverables.
  • Strong attention to detail in data entry accuracy and in following specific process steps within procedural documents.
  • Knowledge of Document Management Systems (Documentum-based is preferred).
  • Recent experience in submitting regulatory submissions using Health Authority Portals.
  • Strong computer skills with demonstrated experience and ability in Microsoft Office suite (Word, Excel, Access, and PowerPoint), and SharePoint.
  • Recent experience with regulatory applications such as CTAs is preferred.

Education and Experience:

  • Bachelors of Arts or Science degree or equivalent professional experience.
  • Minimum of 2 years of regulatory operations experience and in-depth first-hand experience with application electronic submissions.