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    Manager / Senior Manager - Regulatory Affairs

    Eli Lily
    1+ years
    Not Disclosed
    Gurgaon
    10 Jan. 29, 2025
    Job Description
    Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates 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 / Senior Manager - Regulatory Affairs
    Location: Gurgaon, Haryana, India
    Category: Research & Development
    Job Type: Full-Time, Regular
    Job ID: R-78426

    Company Overview

    At Eli Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees worldwide are working to discover and bring life-changing medicines to those who need them, improving the understanding and management of disease, and giving back to our communities through philanthropy and volunteerism. We give our best effort to our work and prioritize people first.

    Role Overview

    The Manager/Senior Manager of Regulatory Affairs will be responsible for managing the operational and technical aspects of regulatory affairs within the affiliate, ensuring compliance with local regulations and contributing to the success of new product registrations, line extensions, and new indications. The role will require close collaboration with cross-functional teams, regulatory authorities, and local affiliates to execute regulatory plans and achieve business objectives.

    Primary Responsibilities

    1. Regulatory Plan Execution

    • Implement the Regulatory Plan in alignment with affiliate business plans and regulatory requirements.
    • Ensure timely submission and approval of high-quality regulatory applications, maintaining regulatory compliance for all products.
    • Support submission of new applications and obtain marketing authorizations.
    • Collaborate with global and regional regulatory contacts, ensuring affiliate needs are voiced and met.
    • Track post-approval activities such as renewals, variations, and periodic reports.
    • Maintain regulatory tools and ensure alignment with compliance metrics.
    • Support affiliate launch teams, anticipating regulatory constraints and delivering outcomes in support of launch plans.
    • Represent the Regulatory Affairs function in Affiliate Lead Team and New Product Planning discussions.
    • Stay updated on regulatory changes and communicate the implications to relevant management and teams.

    2. Regulatory Compliance

    • Ensure internal Regulatory IT tools are up-to-date and accurate.
    • Guarantee that all products comply with local regulations and quality system requirements.
    • Maintain the regulatory archive and ensure current licenses and labels are available.
    • Implement local quality systems in alignment with global quality standards and regulations.
    • Support internal and external audits, assessments, and self-inspections, addressing any compliance issues.
    • Provide regulatory quality oversight for third-party vendors such as regulatory services providers, translators, and graphic agencies.

    3. Labelling

    • Perform the role of Primary, Alternate, or Delegate Affiliate Labelling Responsible Person (ALRP) to ensure product information complies with local regulatory requirements.
    • Follow global labelling procedures, documenting exceptions, and ensuring accurate, high-quality product information.
    • Submit updated product information within designated timelines for approval and implementation.

    4. Process Improvement

    • Align and implement internal regulatory initiatives across cross-functional teams.
    • Actively contribute regulatory expertise to affiliate strategic initiatives and launch readiness efforts.
    • Build and maintain relationships with key regulatory officials and industry stakeholders.
    • Provide regulatory training and education to affiliate teams to foster understanding of regulatory requirements.

    5. Personal and Professional Development

    • Stay informed about local regulations and global regulatory procedures.
    • Participate in external symposia, workshops, or conferences to continuously develop technical expertise.

    Additional Responsibilities (Optional)

    Patient Safety

    • Assist the Affiliate Pharmacovigilance Responsible Person in reporting adverse events and submitting safety reports as per local regulations.

    Product Quality

    • Support the Product Quality Representative in implementing Lilly Global Quality Standards (e.g., GQS-181/CQP-181).
    • Assist with the local Product Complaint system and act as the local responsible person for complaints.

    Minimum Qualifications

    • Bachelor's degree in a relevant scientific field (e.g., Pharmacy, Life Sciences, Chemistry, or Biotechnology).
    • At least 1 year of experience in regulatory affairs, dealing with regulatory agencies, healthcare systems, and marketing needs.
    • Strong teamwork skills, with a focus on delivering results.
    • Ability to adapt to challenging situations and demonstrate good problem-solving abilities.
    • Proficiency in computer/IT skills.
    • Good command of written and spoken English.

    Preferred Skills

    • Strong analytical and problem-solving abilities.
    • Excellent communication and negotiation skills.
    • Project management experience.
    • Ability to prioritize tasks effectively and work independently.
    • Strong understanding of quality systems and regulatory requirements.
    • Ability to establish positive relationships and networks both internally and externally.

    Additional Information

    Lilly is dedicated to helping individuals with disabilities engage in the workforce and ensures equal opportunities during the application process. If you require accommodations to submit a resume, please complete the accommodation request form for further assistance.

    #WeAreLilly

     

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    Seoul |

    Kuala Lumpur :

    Kuala Lumpur |

    Mexico :

    Ciudad de México |

    New Zealand :

    New Zealand |

    North Island :

    Auckland |

    Lima Region :

    Lima |

    Cebu Province :

    Cebu City |

    Philippines :

    Manila |

    Mazovia :

    Warsaw |

    Remote :

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

    Bucharest :

    Bucharest |

    Makkah :

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

    Nišava District :

    Niš |

    Singapore :

    Singapore |

    South Africa :

    Midrand | South Africa |

    Brazil :

    Sao paulo | Brazil |

    South America :

    Peru | Argentina |

    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 |