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Senior Manager 2

2+ years
Not Disclosed
10 Jan. 1, 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: Senior Manager 2
Date: Dec 23, 2024
Location: Ahmednagar - Regulatory Affairs
Company: Sun Pharmaceutical Industries Ltd

Responsibilities:

  1. Manage the proper functioning of the Site Regulatory department, coordinating with other plant departments and corporate regulatory teams to compile data needed for filing Drug Master Files (DMFs) in the USA, Europe, Canada, and other regions during DMF submissions and query responses.
  2. Oversee the annual updates and renewals of DMFs (USDMF, CEP, Canada DMF, MRP, DCP procedures).
  3. Update various changes in the DMF in coordination with the CRA.
  4. Respond to deficiencies received on DMFs from regulatory authorities in collaboration with the CRA.
  5. Address customer queries and provide responses in coordination with the CRA.
  6. Review and approve Change Control and Annual Product Review (APR).
  7. Review and approve Specifications and ATPs.
  8. Inform the CRA about any changes, modifications, incidents, or investigations that may have regulatory implications.
  9. Identify training needs and organize relevant training for the Regulatory and other departments.
  10. Prepare, review, and approve GMP documents.
  11. Authorize extensions for Change Control requirements.
  12. Close Change Control in Trackwise after filing and receiving approval.
  13. Immediately report any quality-related issues upon observation.
  14. Prepare and review GMP documents related to activities.
  15. Follow safety guidelines and use necessary personal protective equipment (PPE) during daily operations.