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Regulatory Affairs Specialist

2-5 years
Not Disclosed
10 July 24, 2024
Job Description
Job Type: Full Time Education: M.Pharm Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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 Opening: Regulatory Affairs Specialist at Sun Pharma, Baroda

Location: Baroda, Gujarat

Position: Regulatory Affairs Specialist

Qualifications: M.Pharm

Experience: 2-5 years

Key Responsibilities:

  1. Data and Document Review: Analyze and review data and documents related to product registrations for various health authorities.

  2. Dossier Compilation: Compile registration dossiers for submission to health authorities, including US-FDA, Health Canada, Europe, Australia/New Zealand, Japan, and Israel.

  3. Response Preparation: Prepare responses to deficiency letters from various regulatory agencies.

  4. Life-Cycle Management: Maintain life-cycle and post-approval changes for drug product registration dossiers.

  5. Regulatory Support: Provide regulatory support to cross-functional departments.

  6. Scientific Advice: Prepare and submit scientific advice to various health authorities.

  7. eCTD Management: Compile, verify, and submit eCTD (Electronic Common Technical Document) submissions through electronic gateways.

How to Apply:

Send your resume to [Hr.tandalja@sunpharma.com]