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Team Member - Lcm

5+ years
Not Disclosed
10 Nov. 28, 2024
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

Division: IPD

Department: IPD

Employment Type: Permanent


Job Purpose

Execute life cycle management activities for Non-Respiratory products across global markets (US, EU, South Africa, ANZ, WHO, PEPFAR, and 150+ countries) to ensure business continuity and regulatory compliance.


Key Accountabilities

  1. Global Change Request Assessment:

    • Review, evaluate, and categorize change requests allocated by the Global Lead (GL) to meet regulatory guidelines, ensuring product launches, commercial needs, and compliance.
  2. Dossier and Variation Package Preparation:

    • Prepare variation packages for Modules 2 to 5 and respond to deficiencies globally to support product launches, ongoing commercialization, and regulatory compliance.
  3. Regulatory Reporting:

    • Prepare annual reports for the US market as per schedule to maintain regulatory compliance.
    • Compile WHO requalification dossiers to ensure continued product licensure.
  4. Re-registration Dossiers:

    • Compile re-registration dossiers for global markets to maintain product licenses and ensure uninterrupted business continuity.
  5. Product Database Management:

    • Maintain and update the product database to enable efficient retrieval, tracking, and monitoring of product statuses.

Educational Qualification:

  • Minimum: Graduate in Pharmacy or Life Sciences

Relevant Experience:

  • At least 5 years of experience in Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing, Analytical Development, or R&D.

Job Location:

  • Vikhroli

Competencies and Skills:

  1. Core Competencies:

    • Collaborate to Succeed
    • Innovate to Excel
    • Perform with Accountability
    • Lead with Empathy
    • Act with Agility
  2. Technical Skills:

    • Strong domain knowledge in regulatory affairs and pharmaceutical life cycle management.
    • Proficiency in regulatory documentation and compliance processes.
  3. Leadership and Management Skills:

    • Effective people management and cross-functional collaboration abilities.