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Associate-Regulatory Affairs

Indivirtus
Indivirtus
3-5 years
Not Disclosed
10 Feb. 24, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ 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: Associate - Regulatory Affairs

Experience Required: 3-5 years of relevant experience
Location:
Mohali/Chandigarh
Compensation: 20-25% rise on current CTC

Key Responsibilities:

  • Preparation of Regulatory Dossiers:

    • Prepare Common Technical Documents (CTD) and electronic Common Technical Documents (eCTD) dossiers for submission to regulatory authorities.

    • Prepare Drug Master Files (DMF) and ensure compliance with regulatory requirements.

  • Technology Transfer Documentation:

    • Assist in the preparation of documents related to technology transfer, including Master Batch Records (BMR), Product Development Reports (PDR), and other relevant technical documentation.

Required Skills:

  • Strong knowledge of regulatory affairs and preparation of regulatory submission dossiers (CTD/eCTD).

  • Experience in handling technology transfer documentation (BMR, PDR).

  • Good understanding of regulatory guidelines and the submission process.