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Business Partner – Regulatory Operations

8-10 years
Not Disclosed
10 Sept. 18, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/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 Title: Business Partner – Regulatory Operations
Location: Chennai, India
Department: Regulatory Affairs
Reports To: Manager
Employment Type: Full-Time

Educational Qualification:

  • Graduate in Life Sciences


Job Purpose:

Lead and manage regulatory operations projects, ensuring quality, compliance, and timely submissions, while coordinating resources and processes to support business objectives.


Key Responsibilities:

Regulatory Operations Management:

  • Develop and manage day-to-day operations using project management and planning tools; create and maintain detailed project timelines.

  • Coordinate and maintain quality, productivity, and adherence to timelines, internal processes, and customer standards.

  • Plan resources to support submissions publishing and regulatory affairs activities, including short- and long-term resource planning.

  • Manage projects by regularly meeting with team leads to identify and resolve issues, ensuring quality and delivery effectiveness.

Process & Documentation:

  • Initiate, author, and/or collaborate on SOPs, work instructions, and workflows for the regulatory operations function.

  • Plan, coordinate, and prepare responses to Requests For Proposals (RFPs), Requests For Information (RFIs), and Requests For Quotes (RFQs).


Required Skills & Competencies:

  • 8–10 years of experience in regulatory operations.

  • Expertise in both Publishing and Submissions.

  • Strong understanding of regulatory information management concepts and tools.

  • Excellent communication and coordination skills.