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    Senior Team Member - Regional Ra

    Cipla
    14+ years
    Not Disclosed
    Vikhroli
    10 Nov. 28, 2024
    Job Description
    Job Type: Full Time Education: MSc. 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: Regulatory Affairs

    Department: Regulatory Affairs

    Sub-Department: Emerging Markets / SAGA Region

    Employment Type: Permanent

    Job Purpose

    1. Conduct original dossier review, compilation, and submission.
    2. Manage the product life cycle, including renewals, retentions, and variation submissions, to ensure timely approvals and market continuity.
    3. Ensure the availability of compliant products for market placement by meeting regulatory and business requirements.

    Key Accountabilities

    1. Regulatory Strategy Development

    • Collaborate with cross-functional teams to define regulatory strategies for CGA countries during product development.
    • Provide inputs on regulatory requirements, document needs, and updated guidelines throughout the development phase.
    • Coordinate with departments to gather and prepare necessary documents for submission.

    2. Submission Review and Compilation

    • Review, compile, and submit dossiers for CGA core markets (e.g., WHO, USFDA).
    • Ensure compliance with regulatory authority requirements for complete and accurate submissions.
    • Track dossier deficiencies, address them promptly, and monitor product approvals to meet timelines.

    3. Life Cycle Maintenance

    • Evaluate post-approval changes and categorize them as per regulatory guidelines.
    • Compile and submit variations, requalification dossiers, and renewals for CGA core countries.
    • Ensure timely submissions to maintain product licenses, meet renewal deadlines, and avoid lapses.

    4. Database Management

    • Maintain regulatory databases (e.g., PRC database & GPL) for tracking product life cycle history.
    • Provide product status updates to cross-functional teams as requested.

    5. Business and Technical Support

    • Provide regulatory information to support business tenders, RFQs, and labelling changes.
    • Engage with external stakeholders and Local Technical Representatives (LTRs) for timely submission and approval processes.
    • Support pharmacovigilance (PV) requirements with timely regulatory inputs.

    6. Stakeholder Communication

    • Maintain ongoing communication with internal and external stakeholders, including LTRs and regulatory agencies, to ensure seamless coordination and timely approvals.

    Major Challenges

    • Managing strategy changes and subsequent rework leading to potential delays.
    • Handling late document availability from cross-functional teams, affecting submission timelines.
    • Addressing non-budgeted submissions, creating workload imbalances.
    • Overcoming inefficiencies in software support for submission processes.

    Key Interactions

    Internal:

    • Cross-functional teams (R&D, Unit, ADL ROC, CQA, CDT, LCM): Daily
    • Business: Strategy discussions (Ad hoc)
    • Packaging and Clinical/Medical Writing: Data generation/amendments (Ad hoc/Daily)

    External:

    • Regulatory agencies: Updates, reviews, and approvals (Ad hoc)
    • LTRs: Submission and life cycle management (Daily/Ad hoc)
    • Suppliers: Data provision throughout submissions (Ad hoc)

    Dimensions

    • Countries Covered: 29
    • Marketing Authorizations Managed: 350
    • Customers: 14
    • Regulatory Agencies: 2

    Key Decisions

    Decisions:

    • Classification and type of change amendments.
    • Regulatory advice for quality issues and deficiency responses.
    • Submission strategies for marketing authorizations.

    Recommendations:

    • Regulatory input during product development stage gates.
    • Strategic decisions for maintaining compliance and approval timelines.

    Educational Qualification:

    • Master’s in Science

    Relevant Work Experience:

    • 14 years in regulatory affairs within the pharmaceutical industry, focusing on the emerging market/SAGA region.

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    Warsaw |

    Remote :

    Castlebar | Lousiana | Bountiful | Leinster | Bishop | Lenexa | Belgium | Slovakia | Hammond | Zaragoza | Remote - Middle East | French | Switzerland | Nairobi | Remote, USA | Riga | Texas | Thailand | Medan | Remote - Africa | Remote - South America (Latin Americal) | Tulsa | Blue Bell | Remote - Europe | Ireland | Manipal | Hungary | Xzagreb | Victoria | Remote | Minnesota | Springville | McFarland | Faridabad | Green Way | Melbourne |

    Bucharest :

    Bucharest |

    Makkah :

    Khulais | Jeddah | Rabigh | Riyadh | King Abdullah Economic City | Najran |

    Nišava District :

    Niš |

    Singapore :

    Singapore |

    South Africa :

    Midrand | South Africa |

    Brazil :

    Sao paulo | Brazil |

    South America :

    Argentina | Peru |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Sweden :

    Sweden |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hà Nội | Hanoi |

    Ho Chi Minh :

    Ho Chi Minh City |