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Regulatory Affairs

1-3 years
Not Disclosed
10 April 20, 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:
Regulatory Affairs

Location:
Pune

Educational Requirement:

  • M.Pharm or Bachelor's degree with relevant experience

Experience & Skills:

  • 1-3 years of experience in Regulatory Affairs

  • Strong communication and drafting skills

Key Responsibilities:

  • Identify product registration requirements and prepare dossiers for submission

  • DMF (Drug Master File) preparation and compilation

  • Risk management related to regulatory processes

  • Ensure product quality and compliance with applicable standards

  • Collaborate with cross-functional teams on various projects

  • Optimize production processes to meet regulatory standards

How to Apply: