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Senior Analyst - Regulatory Affairs

2.5-5 years
₹6 – ₹10 LPA
1 Aug. 6, 2025
Job Description
Job Type: Full Time Education: B-Tech 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

Senior Analyst – Regulatory Affairs
📍 Location: Chennai
🕒 Experience: 2.5–5 Years
💼 Industry: Regulatory Affairs / Medical Devices

Job Overview:
We are seeking a detail-oriented Senior Analyst in Regulatory Affairs to join our development team. This role involves handling end-to-end medical device labeling activities, ensuring compliance with regulatory standards, and collaborating with internal and external stakeholders to meet project goals.

Key Responsibilities:

  • Ensure accurate and compliant medical device labeling using Adobe Illustrator and InDesign.

  • Apply proofreading tools and version comparison techniques to maintain document quality.

  • Adhere to labeling standards, UDI guidelines, regulatory symbols, and IFU formatting.

  • Maintain, troubleshoot, and enhance existing labeling content per business/client needs.

  • Coordinate with internal teams and customers to gather requirements for document development.

  • Offer technical guidance to junior team members.

  • Manage documentation for CMMi and client requirements.

  • Deliver timely client support including ticket resolution, data presentation, and monitoring deliverables.

Qualifications:

  • B.Tech or equivalent degree in a relevant field.

Required Skills:

  • Labeling Requirements (Domain Competency – ERS)

  • Proficiency in Adobe Illustrator & Adobe InDesign

  • Strong attention to detail and organizational abilities

  • Understanding of print production and regulatory documentation

  • Familiarity with UDI, regulatory symbols, and IFU formats

No. of Positions: 1

💰 Estimated Salary: ₹6 – ₹10 LPA (based on industry standards for Chennai and experience range)

Apply Now