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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 functioning of the Site Regulatory department and collaborate with plant and corporate regulatory teams to compile data for Drug Master File (DMF) submissions and query responses across global markets, including the USA, Europe, Canada, and other regions.
  2. Oversee the annual updating and renewal of DMFs (USDMF, CEP, Canada DMF, MRP, DCP procedures).
  3. Coordinate updates to DMFs in alignment with CRA (Clinical Research Associates).
  4. Address deficiencies received on DMFs from regulatory authorities in partnership with CRA.
  5. Respond to customer queries in coordination with CRA.
  6. Review and approve Change Control and Annual Product Reviews.
  7. Review and approve Specifications and ATPs (Approved Testing Procedures).
  8. Inform CRA of any changes, modifications, incidents, or investigations with a regulatory impact.
  9. Identify training needs within Regulatory and other departments and organize relevant training.
  10. Prepare, review, and approve GMP (Good Manufacturing Practices) documents.
  11. Authorize extensions for Change Control as needed.
  12. Complete Change Control closing in TrackWise after filing and obtaining approval.
  13. Promptly report any quality-related issues observed.
  14. Ensure adherence to safety protocols and the proper use of personal protective equipment during daily activities.