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Associate-Regulatory Affairs

3-5 years
Not Disclosed
4 Feb. 16, 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: Associate – Regulatory Affairs

Experience: 3-5 years of relevant experience

Salary: 20-25% rise on current CTC

Job Responsibilities:

  1. Prepare Common Technical Document (CTD) and electronic Common Technical Document (eCTD) dossiers/Drug Master Files (DMF) as per regulatory requirements.
  2. Compile and review regulatory submissions to ensure compliance with global regulatory standards.
  3. Prepare documents related to technology transfer, including Batch Manufacturing Records (BMR), Product Development Reports (PDR), and other relevant documentation.
  4. Coordinate with internal teams to ensure timely submission of regulatory documents.
  5. Stay updated with the latest regulatory guidelines and requirements.