Regulatory Affairs (Senior) Manager

Position

Regulatory Affairs (Senior) Manager

Direct Report

Position Summary

This position will manage multiple immunology/oncology projects by providing support for the delivery of high-quality regulatory submissions, including managing project deliverables and timelines, preparing scientific and regulatory documents that align with global regulatory standards in collaboration with the cross-functional team.

Key Responsibilities

  • Lead the regulatory publication and submission for Marketing applications (New Drug Applications [NDAs]/Biologics License Applications [BLAs])/Investigational New Drug [IND] application sections/Pre-IND [PIND]/regulatory meetings
  • Assist the preparation of technical files including Clinical study reports (CSR), Investigator Brochures (IB), Risk Management Plans, Responses to Regulatory Agency Questions, etc.
  • Manage all regulatory submission publishing deliverables including eCTD placement and structure within eCTD Modules (1-5), study tagging files (STF), submission quality control (QC), transmission of submissions to US FDA via Electronic Submissions Gateway (Global Submit)
  • Create standard operating procedures (SOPs) and templates for regulatory documents. Draft Regulatory procedures and support updates to other Quality System procedures as needed
  • Participate in the development of timelines for regulatory documents and lead preparation of assigned deliverables
  • Contribute to regulatory submission strategy for teams in assigned product areas
  • Serve as functional area representation on product teams (e.g., Global Regulatory Team, Global Safety Team, Label Working Group)
  • Provide functional area input for Global Regulatory Plan and team goals
  • Work with contract and freelance writers
  • Participate in training and mentoring of junior regulatory specialist/medical writers
  • Participate in departmental and cross-departmental initiatives, as appropriate

Qualifications

  • Doctorate degree OR Master’s degree and 3 years of directly related experience OR Bachelor’s degree and 5 years of directly related experience
  • Working knowledge of US regulatory requirements and guidance for submission requirements, document management, submission management, electronic document publishing and electronic submission publishing
  • Advanced knowledge of Microsoft (MS) Word, MS Excel, Adobe Acrobat, electronic document management systems, document publishing tools, publishing systems (i.e, InSight Publisher), eCTD validation, eCTD tools (e.g., Global Submit), and viewing tools
  • Clear understanding of US FDA laws, regulations and guidance documents related to electronic submissions including the eCTD structure and Word templates and styles
  • Direct experience submitting IND, NDA, BLA dossier to the FDA
  • Ability to manage several complex projects in parallel and adapt to changing priorities
  • Ability to work with project team members in producing compliant deliverables