Regulatory Operations Project Manager, eCTD Submissions Publishing, Pharma, Regulatory Operations

We have an excellent job opportunity available as a Regulatory Operations Project Manager, eCTD Submissions Publishing, Pharma, Regulatory Operations!

• Prepare applicable Module 1 documents per appropriate regional submission and route for appropriate review and approval
• Partner with the Clinical Regulatory Ops Project Manager to retrieve, publish, and submit Modules 1-5 reports/documents and combine files into electronic submissions (eCTD) according to the master table of contents or Content Plan for the dossier. Examples include:
  • retrieve and publish CRFs and datasets required for regulatory submissions
  • retrieve and publish literature references (bibliographies)
  • retrieve, publish, and submit U.S. FDA required periodic reports
  • retrieve, process, publish, and submit U.S. FDA required post-Marketing supplements and amendments
  • ensure compliance with 30-Day Packet and Med Watch submissions
  • create different dossiers for Europe, the U.S., Canada or other supported worldwide markets. Dossiers are distributed to regulatory agencies and client affiliate offices worldwide
• Submit and archive submitted registrations, incoming correspondence, and Records of Contact with Regulators assuring all metadata fields are complete in eFiles or RIM
• Provide eCTD expertise and partners with Regulatory Project Managers, Regulatory Scientists, other publishing centers, vendors, and/or other contributing areas to align on submission specific requirements to ensure adherence to submission regulations and guidelines.

• 7+ years direct Regulatory Publishing experience and operations experience within a regulated environment
• Understanding of Form 1571, 356 H
• Experience doing end to end publishing, including cover letter creation
• Experience and knowledge in formatting and publishing medium/high complexity major applications, amendments, and supplements (manufacturing, nonclinical, clinical)
• Experience with CTD/eCTD structure and format
• Experience using eCTDXpress publishing system
• BS Degree in Life Sciences or computer science preferred or equivalent work experience
• Experience with Original IND and initial NDA/BLA, NDS and EU MAA submissions including complex lifecycle submissions
• Strong knowledge of global health authority and ICH regulations and guidance as it pertains to format and submission structure