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Manager - Regulatory Affairs

8-12 years
Not Disclosed
10 Dec. 31, 2024
Job Description
Job Type: Full Time Education: M.Sc./M.Pharm 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: Manager - Regulatory Affairs

Date: December 7, 2024

Location: Airoli, MH, India

Company: Lupin


Job Description

The Manager - Regulatory Affairs will be responsible for managing regulatory activities related to the preparation and submission of DMFs, ANDAs, MAAs, and other regulatory submissions. This role includes reviewing documentation, responding to queries, preparing updated API folders, and ensuring compliance with regulatory standards.


Key Responsibilities

  1. DMFs and Technical Packages Review:

    • Review original and updated Drug Master Files (DMFs) and technical packages to ensure compliance with regulatory requirements.
  2. Vendor Query Management:

    • Review responses to queries received from outsourced and alternate vendors, ensuring that all necessary information is provided to meet regulatory standards.
  3. Supporting Document Review:

    • Review supporting documents, declarations, and administrative documents for regulatory submissions to ensure accuracy and completeness.
  4. Alternate Vendor Data Review:

    • Compare and evaluate data for APIs from alternate vendors in alignment with existing vendor data.
  5. API Folder Preparation:

    • Prepare updated API folders/sections for regulatory submissions, including ANDAs and MAAs.
  6. Regulatory Checklist Sign-off:

    • Review and sign off on checklists and Verification (VER) documents, providing regulatory comments as necessary.
  7. Change Notifications:

    • Review change notifications related to regulatory compliance and ensure appropriate actions are taken.
  8. Vendor Audits:

    • Conduct regulatory audits of vendors to ensure compliance with regulatory requirements and standards.

Education Qualifications

  • Post Graduate Degree (preferably in Pharmacy, Life Sciences, or a related field)

Relevant Work Experience

  • 8 to 12 years of experience in Regulatory Affairs, with significant experience in the pharmaceutical industry, including review of technical packages, vendor management, and regulatory submissions.

This position provides an opportunity to manage complex regulatory affairs processes, ensuring successful submissions and compliance with regulatory standards. If you have the required experience and qualifications, we encourage you to apply for this role.