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    Manager

    Enzene Biosciences Ltd.
    14-17 years
    Not Disclosed
    Remote
    10 Feb. 10, 2025
    Job Description
    Job Type: Remote 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

    Position: Manager - CMC-RA
    Department: CMC-RA
    Location: Unit 3
    Experience Required: 14-17 years
    Educational Qualification: M.E/M.Tech/MS, M.Pharm, M.Sc
    Date Posted: 30-11-2023

    Job Summary:

    We are seeking an experienced Manager for our CMC-RA team to provide regulatory support across the lifecycle of biopharmaceutical products, including biologics, biosimilars, novel biologics, and vaccines. This role requires strong project management skills, leadership experience, and deep regulatory knowledge. The Manager will work closely with cross-functional teams and health authorities to ensure compliance with global regulatory requirements.

    Key Responsibilities:

    1. Regulatory Framework Expertise:

      • Understand and apply the regulatory framework for biological therapeutic products (biologics, biosimilars, novel biologics, and vaccines) across India and ROW markets.
      • Stay updated with regional regulatory trends and requirements for various applications and procedures.

    2. Regulatory Documentation & Input:

      • Provide regulatory input on procedural and documentation requirements as defined by Health Authorities, including Indian regulatory authorities, Emerging Markets, and ROW countries.
      • Review and provide feedback on documents such as RCGM-PCS, CTA, MAA, PAC, study protocols, and regulatory maintenance documents.

    3. Analysis & Special Designations:

      • Analyze regulatory procedures and special designations used during development, authorizations, and product extensions.
      • Ensure adherence to best practices in managing applications and regulatory procedures during interactions with health authorities.

    4. Regulatory Maintenance Submissions:

      • Lead and contribute to the planning, preparation, and delivery of regulatory maintenance submissions, including authoring documentation when required.
      • Handle increasingly complex submissions as experience grows.

    5. Cross-Functional Collaboration:

      • Liaise closely with cross-functional teams aligned with product responsibilities to ensure smooth regulatory operations.
      • Coordinate and communicate with different departments regarding regulatory input and status updates.

    6. Project Management & Planning:

      • Develop and maintain submission delivery plans and content plans for ongoing projects.
      • Provide proactive status updates on regulatory projects and highlight unforeseen changes in resource demand to the function head.

    7. Support Operational Teams:

      • Support operational and project teams with regulatory requirements, ensuring smooth project execution.
      • Ensure that regulatory needs are met in a timely and efficient manner.

    8. Team Leadership & Mentorship:

      • Provide coaching, mentoring, and knowledge sharing within the team to foster growth and skill development.
      • Lead by example, ensuring compliance and fostering a culture of continuous improvement.

    9. Process Improvement:

      • Contribute to the development and implementation of process improvements within the regulatory function.
      • Identify opportunities to streamline processes, reduce inefficiencies, and improve outcomes.

    Skills & Qualifications:

    • Educational Qualification:

      • M.E/M.Tech/MS, M.Pharm, M.Sc or a relevant field.

    • Experience:

      • 14-17 years of relevant regulatory experience in the biopharmaceutical industry, particularly in biologics, biosimilars, and vaccines.

    • Core Skills:

      • In-depth knowledge of the regulatory product maintenance process for biological therapeutic products.
      • Strong project management skills with the ability to lead and manage multiple projects simultaneously.
      • Leadership experience, including the ability to guide and mentor a multi-disciplinary project team.

    • Additional Skills:

      • Proven track record of successful interactions with health authorities and cross-functional teams.
      • Strong analytical and problem-solving abilities.
      • Ability to adapt to a dynamic and changing regulatory environment.

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    Warsaw |

    Remote :

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

    Bucharest :

    Bucharest |

    Makkah :

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

    Hanoi | Hà Nội |

    Ho Chi Minh :

    Ho Chi Minh City |