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Reg Affairs Officer 2

2+ years
Not Disclosed
10 Dec. 5, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description: Regulatory Submission Coordinator

Key Responsibilities and Accountabilities:

  • Participate in the creation of submission content plans in Regulatory Document Management Systems or health authority submission portals (e.g., IRIS, CTIS), and monitor the progress of submissions.
  • Author administrative sections (cover letters, submission forms) and manage the preparation of other routine submission documents.
  • Examples of submissions include investigator submissions, annual reports, PSURs, DSURs, Orphan Drug annual reports, and IND Safety Reports.
  • Coordinate activities with other functional teams to ensure timely and accurate submission of documents.
  • Oversee submission documents through review cycles, providing guidance on uploading and managing documents in the regulatory submission document management system.
  • Support affiliates as needed and coordinate team meetings for major and routine submissions aligned with the Global Regulatory Lead (GRL) and EU/US Regulatory Strategy Leads.
  • Manage the overall completeness of scheduled submissions and collaborate with the Publishing Lead to track document status and submission timelines.
  • Review published outputs for accuracy and completeness.
  • Contribute to operational excellence initiatives and improvement projects.
  • Preferred EU time zone as requested by the client.

About IQVIA:
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com