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    Manager Ii - Health Authority Communications

    Sun Pharma
    5+ years
    Not Disclosed
    Mumbai
    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: Manager II - Health Authority Communications
    Date: Dec 25, 2024
    Location: Tandalja - R&D
    Company: Sun Pharmaceutical Industries Ltd

    Position: Manager II – Health Authority Communications

    Reports To: Head of Health Authority Communication and Correspondence
    Department: Global Quality
    Functional Area: Global Quality
    Location: Mumbai

    Position Summary:

    The Manager II – Health Authority Communications will play a key role in supporting global health authority communications and ensuring regulatory compliance throughout the organization. This position works closely with the Head of Health Authority Communication and Correspondence to coordinate regulatory responses, manage quality deliverables, and prepare materials for regulatory meetings.

    The role involves ensuring compliance with all regulatory requirements, Good Manufacturing Practices (GxP), and other applicable department programs. The Manager II will assist in identifying and resolving compliance risks and support the remediation process.

    This position is ideal for a Quality professional with experience in manufacturing environments (e.g., aseptic, solid oral dose) and Quality Management Systems, aiming to contribute to health authority communications.

    Key Responsibilities:

    1. Health Authority Correspondence Management:
      Assist in reviewing and preparing scientifically accurate, compliant responses to health authority queries and inspection observations. Collaborate with site teams to gather data and draft responses. Track and document all regulatory communication activities in regulatory databases in a timely manner.

    2. Quality Management System Analysis:
      Analyze inspection, audit, and QMS findings to identify areas for global risk mitigation. Support internal teams in developing corrective actions.

    3. Inspection Readiness:
      Provide support for regulatory audits, internal/external inspections, and mock inspections. Review documents to ensure compliance with current regulations.

    4. Compliance Tracking and Reporting:
      Monitor regulatory updates, perform gap assessments on regulatory requirements (especially in aseptic environments), and ensure compliance with quality management.

    5. Additional Assignments:
      Perform other tasks as needed.

    Minimum Education/Experience Requirements:

    • Degree in Science/Pharmacy related field required.
    • 7+ years of experience in quality within the pharmaceutical industry, preferably in an aseptic environment. Microbiology experience is a plus.
    • Knowledge of GxP, cGMP, Quality Systems, and regulatory requirements.
    • Proficient in Quality Management Systems (QMS) with experience in analyzing QMS data.
    • Significant experience in global health authority inspections and audits. Experience with FDA, MHRA, EMA, or WHO responses is preferred.

    Required Success Attributes:

    • Deep understanding of Quality Management Systems, including CAPAs and deviations.
    • Proficiency with regulatory tracking systems and Microsoft Office Suite.
    • Excellent technical writing, attention to detail, collaboration, and project management skills.
    • Strong verbal and written communication skills.
    • High ethical standards and adherence to policies.
    • Ability to manage multiple priorities in a fast-paced environment.

    Secondary Success Attributes:

    • Commitment to continuous learning and staying updated with industry best practices.
    • Ability to adapt quickly to new knowledge and challenges.
    • Participation in global harmonization activities.

    Working Environment/Physical Requirements:

    • Work performed in both office and manufacturing/packaging environments.
    • Moderate to loud noise levels in production areas.
    • Must comply with gowning requirements and wear personal protective equipment in controlled areas.

    Delegation of Responsibility:

    • Upward Delegation: Strategic corporate responsibilities to higher levels.
    • Downward Delegation: Not applicable.

    This job description reflects the general nature and level of work being performed. Other duties and responsibilities may be assigned as needed.

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    Nišava District :

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    Singapore :

    Singapore |

    South Africa :

    Midrand | South Africa |

    Brazil :

    Brazil | Sao paulo |

    South America :

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    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Sweden :

    Sweden |

    Taipei :

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    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hanoi | Hà Nội |

    Ho Chi Minh :

    Ho Chi Minh City |