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    Manager

    Sun Pharma
    10-15 years
    Not Disclosed
    Baroda
    10 Jan. 5, 2025
    Job Description
    Job Type: Full Time Education: MSc/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

    Manager - Lifecycle Management (R&D)
    Date: January 1, 2025
    Location: Tandalja - R&D, Sun Pharmaceutical Industries Ltd

    Sun Pharmaceutical Industries Ltd, a global leader in the pharmaceutical industry, seeks a Manager for lifecycle management of development products within our R&D department. This role involves ensuring compliance with regulatory requirements and managing various aspects of the product development lifecycle, particularly in early-phase development.

    Key Responsibilities:

    Lifecycle Management and Knowledge Management

    • Oversee lifecycle management of development products in line with ICH guidelines.
    • Manage and document process changes during early-phase development.
    • Ensure regulatory compliance of clone development and cell banking documentation.

    Regulatory Compliance and Documentation

    • Review and ensure compliance of product development documents such as process development reports, process descriptions, and process control strategies.
    • Ensure analytical developments such as method development, method qualification, and validation are aligned with the latest quality and regulatory requirements.
    • Develop, implement, and continually improve the Quality Management System (QMS) at R&D, ensuring alignment with corporate and site QA standards.

    Data Verification and Documentation Practices

    • Verify laboratory data and ensure compliance with ALCOA++ principles (Attributable, Legible, Contemporaneous, Original, and Accurate).
    • Ensure good documentation practices (GDP) and accurate data reporting in line with industry standards.
    • Control the issuance of working copies and verification of raw data, ensuring proper archival of soft and hard copies of documents.

    Regulatory Filing and CMC Review

    • Compile and review process and analytical documents for regulatory filing and CMC review.
    • Assist with dossier writing for regulatory agencies such as USFDA, EMA, and CDSCO.
    • Maintain audit readiness at all times, ensuring all documentation is prepared for regulatory agency, client, and business partner audits.

    Audit and Inspection Readiness

    • Respond to audit queries from regulatory agencies, clients, and business partners.
    • Ensure the department is always audit-ready, maintaining high standards of quality and compliance.

    Education and Experience:

    • MSc in Life Sciences or M. Pharm (Quality).
    • 10-15 years of experience in quality assurance within the pharmaceutical industry.
    • Strong understanding of regulatory guidelines (RCGM, CDSCO, ICH, ISPE).
    • Exposure to product development, analytical development, CMC, and regulatory filing for recombinant products.
    • Experience with dossier writing for global markets such as USFDA, EMEA, Japan, and India.
    • Familiarity with biosimilar and biologics regulatory requirements, particularly for USFDA, EMEA, Japan, and India.
    • Prior experience in lifecycle management for global product development is advantageous.
    • Experience dealing with international inspections/audits from regulatory agencies and clients is preferred.
    • Excellent verbal and written communication skills in English are essential.

    Key Competencies:

    • Regulatory Knowledge: In-depth understanding of international regulatory requirements, including for biosimilars and biologics.
    • Quality Management Systems: Expertise in developing and maintaining robust QMS within R&D environments.
    • Dossier Writing: Proven experience in preparing dossiers for regulatory submission.
    • Audit Readiness: Ability to maintain a state of audit readiness and handle queries from regulatory bodies and stakeholders.
    • Communication Skills: Strong verbal and written communication abilities to interact effectively with internal teams, regulatory agencies, and external partners.

    Sun Pharmaceutical Industries Ltd offers a dynamic and challenging environment for professionals committed to advancing scientific innovation and regulatory compliance in the pharmaceutical industry. If you are a highly experienced quality assurance professional with a passion for R&D and regulatory affairs, this role provides an excellent opportunity to grow and make a significant impact on global product development.

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