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    Associate Director-Regulatory Liasoning

    Lilly
    7+ years
    Not Disclosed
    Gurgaon
    10 Jan. 16, 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

    Associate Director - Regulatory Affairs and Liaisoning
    Location: Gurgaon, Haryana, India
    Reports to: Director - Regulatory Affairs & Pharmacovigilance

    At Lilly, we unite caring with discovery to make life better for people around the world. As a global healthcare leader based in Indianapolis, Indiana, our employees work relentlessly to discover and deliver life-changing medicines, improve disease understanding, and give back to communities through philanthropy and volunteerism. We're seeking individuals who are determined to make life better for people around the world.

    Job Summary:

    The Associate Director - Regulatory Affairs and Liaisoning will oversee regulatory liaison activities and manage communication with key regulatory bodies in India. This includes the Central Drugs Standard Control Organization (CDSCO), Ministry of Health and Family Welfare (MoHFW), Department of Pharmaceuticals, National Institute of Biologicals (NIB), Indian Pharmacopoeia Commission (IPC), Central Drugs Testing Laboratory (CDTL), and other relevant authorities. This role ensures compliance with local regulations and facilitates product registrations and maintenance.

    Key Responsibilities:

    • Regulatory Compliance: Ensure all regulatory activities align with local regulations and guidelines established by CDSCO, MoHFW, NIB, IPC, CDTL, and other authorities.
    • Liaison with Regulatory Bodies: Serve as the primary contact between the company and regulatory authorities, addressing queries and issues to ensure smooth operations.
    • Product Registration: Manage product registration processes for new products, line extensions, and new indications, ensuring timely submission and approval.
    • Documentation: Prepare, review, and submit regulatory documents such as applications, variations, renewals, and responses to regulatory queries.
    • Regulatory Strategy: Develop and execute strategies to meet the company’s business goals and ensure successful product registrations.
    • Cross-functional Collaboration: Work closely with R&D, Quality Assurance, and Marketing to ensure regulatory alignment and adherence to timelines.
    • Regulatory Intelligence: Monitor changes in regulations, providing updates and recommendations to management, while maintaining relevant repositories.
    • Training and Development: Guide internal teams on regulatory requirements and best practices.
    • Stakeholder Management: Build relationships with key stakeholders, including government officials and industry associations.
    • Risk Management: Identify regulatory risks and implement strategies to mitigate potential impacts on operations.

    Qualifications:

    • Bachelor’s degree in Pharmacy, Life Sciences, or a related field; advanced degree preferred.
    • Minimum 8 years of experience in regulatory affairs, preferably within the pharmaceutical industry or a multinational company.
    • In-depth knowledge of Indian regulatory requirements, particularly those of CDSCO, MoHFW, NIB, IPC, and CDTL.
    • Strong communication and interpersonal skills, with the ability to build and maintain relationships with regulatory bodies.
    • Excellent organizational and project management skills, capable of managing multiple tasks and deadlines.
    • Proficiency in regulatory documentation and submission processes.

    Preferred Skills:

    • Experience in regulatory liaison roles or similar positions.
    • Familiarity with global regulatory guidelines.
    • Ability to work independently and as part of a team.
    • Strong analytical and problem-solving skills.

    Lilly is committed to providing equal employment opportunities and accommodation for individuals with disabilities. If you need assistance during the application process, please complete the accommodation request form on our website.

    Lilly values diversity and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.

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    Bucharest |

    Makkah :

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

    Nišava District :

    Niš |

    Singapore :

    Singapore |

    South Africa :

    Midrand | South Africa |

    Brazil :

    Brazil | Sao paulo |

    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 |