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Senior Regulatory Associate

0-2 years
Not Disclosed
10 May 28, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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 Title: Senior Regulatory Associate


Job Overview

We are seeking a Senior Regulatory Associate to manage the publishing, dispatching, and archiving of regulatory submissions while ensuring compliance with agency standards and supporting audits.


Key Responsibilities

  • Publish, dispatch, and archive regulatory submissions in formats recommended by agencies

  • Support regulatory audits and related compliance activities

  • Ensure timely delivery of high-quality regulatory submissions according to client and internal processes

  • Prepare submission-ready documents for electronic submissions, including formatting, hyperlinking, and processing MS Word and Adobe Acrobat files

  • Maintain up-to-date knowledge of agency standards and procedures for regulatory submissions

  • Troubleshoot document issues in Adobe Acrobat and MS Word

  • Manage technical aspects and provide status updates for assigned submissions

  • Collaborate with cross-functional teams for planning, preparation, publishing, and quality control of submissions

  • Use various publishing and validation tools with prior experience

  • Train and mentor junior staff members

  • Assist in revising department SOPs, work instructions, and training materials


Desirable Skills and Experience

  • Prior experience in publishing and regulatory submissions required

  • Strong knowledge of document management tools and processes

  • Excellent attention to detail and quality standards

  • Ability to work collaboratively and mentor junior staff