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Business Partner – Regulatory Operations

8-10 years
Not Disclosed
10 May 29, 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

 

Business Partner – Regulatory Operations


Job Summary

We are seeking an experienced Business Partner in Regulatory Operations to oversee and manage day-to-day operational activities, ensuring quality, productivity, and adherence to regulatory standards while supporting submissions publishing and regulatory affairs functions.


Key Responsibilities

  • Develop and manage daily operations using project management and planning tools

  • Create and maintain detailed project timelines to track progress

  • Coordinate quality and productivity efforts, ensuring adherence to timelines and internal/customer standards

  • Plan and allocate resources for submission publishing and regulatory affairs activities, including short- and long-term resource planning

  • Manage projects effectively by regularly meeting with team leaders to identify and resolve issues and monitor delivery quality

  • Initiate, author, or collaborate on SOPs, work instructions, and workflows for regulatory operations

  • Plan and prepare responses for Requests for Proposals (RFPs), Requests for Information (RFIs), and Requests for Quotes (RFQs)


Desirable Skills and Experience

  • 8–10 years of experience in regulatory operations

  • Expertise in both Publishing and Submissions processes

  • Strong understanding of information management tools and concepts essential for regulatory operations

  • Excellent communication and interpersonal skills

  • Proven ability to manage complex projects and coordinate cross-functional teams effectively