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Manager

10+ years
Not Disclosed
10 Dec. 4, 2024
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 Summary

The Manager of Lifecycle Management and Regulatory Compliance is responsible for overseeing the lifecycle management of development products in alignment with ICH guidelines. This role ensures the management of process changes during early-phase development, along with reviewing key documentation for clone development, cell banking, and regulatory compliance. The manager will be responsible for product development documentation, analytical developments, and ensuring all processes meet the latest regulatory requirements. The position also includes managing the development and continual improvement of the Quality Management System (QMS) at R&D, and maintaining audit readiness at all times.

Essential Job Functions

  1. Lifecycle Management & Knowledge Management

    • Oversee the lifecycle management of development products in accordance with ICH guidelines.
    • Ensure the proper management of process changes during early-phase development.
  2. Documentation Review & Compliance

    • Review clone development, cell banking documentation, and product development documents (e.g., process development reports, process descriptions, process control strategy).
    • Ensure compliance with regulatory standards in these documents.
  3. Analytical Development & Validation

    • Review method development, qualification/validation protocols and reports, ensuring alignment with quality and regulatory requirements.
  4. Quality Management System (QMS)

    • Develop, implement, and continually improve the QMS for R&D through SOPs, manuals, training, and audits.
    • Ensure alignment of QMS with corporate and site-specific QA standards.
  5. Data Integrity & Documentation Practices

    • Verify laboratory data and ensure adherence to good documentation practices (ALCOA++), maintaining the integrity of raw data.
    • Ensure proper control, issuance, and archival of documents per ALCOA+ principles.
  6. Regulatory Filing & CMC Review

    • Compile and review process and analytical documents for regulatory filing and CMC review.
    • Ensure compliance with regulatory guidelines for biologics and biosimilars (USFDA, EMEA, Japan, CDSCO, etc.).
  7. Dossier Writing & Audit Readiness

    • Lead dossier writing for regulatory filing in various countries such as the USFDA, EMEA, and India.
    • Ensure audit readiness at all times, defending the QMS and responding to audit queries from regulatory agencies, clients, and business partners.

Education & Experience Requirements

  • Education: MSc in Life Sciences or M. Pharm (Quality).
  • Experience: Minimum 10-15 years of experience in quality assurance.
  • Regulatory Knowledge: Strong understanding of regulatory guidelines (RCGM, CDSCO, ICH, ISPE).
  • Product Development & Regulatory Filing: Exposure to product development, analytical development, CMC, regulatory filing for recombinant products, and regulatory requirements for biologics.
  • International Experience: Experience with regulatory filings and inspections in regulated markets (EMA/FDA/PMDA/TGA/HC/ANVISA) is preferred.
  • Communication: Strong verbal and written communication skills in English are essential.
  • Experience with Audits: Previous experience of facing international inspections and audits is preferred.