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2+ years
Not Disclosed
10 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: Executive – Regulatory Affairs

Location: Dholka, India

Category: Regulatory Affairs

Company: Cadila Pharmaceuticals Ltd

Job Code: 18013808

Job Status: Active

Job Responsibilities:

  • Prepare applications for ANDA, IND, and NDA submissions to USFDA and other regulatory bodies.
  • Upload documents in e-CTD compilation and manage regulatory software such as Lorenz validation and TVT.
  • Monitor regulatory queries and respond in a timely manner, ensuring effective communication with the FDA.
  • Prepare and submit post-approval amendments, along with executive summaries for regulatory submissions.
  • Track the review progress of applications and coordinate with relevant teams for approvals.
  • Provide regulatory guidance and inputs to cross-functional technical teams.