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    Manager/Sr. Manager-Regulatory Affairs

    Lilly
    2+ years
    Not Disclosed
    Gurgaon
    10 Nov. 19, 2024
    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: 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 headquartered in Indianapolis, Indiana, our employees work to bring life-changing medicines to those in need, improve the understanding and management of disease, and give back through philanthropy and volunteerism. We’re looking for passionate individuals who are determined to make a difference.

    Purpose:

    The Associate Director - Regulatory Affairs is responsible for regulatory planning and managing compliance to meet business needs across the affiliate and responsible countries. This includes regulatory liaison, ensuring timely registration and maintenance of new and existing products, and managing relationships with key regulatory bodies. The role involves ensuring compliance with local and global regulations, including product registration, labeling, pharmacovigilance activities, and responding to regulatory changes.

    Primary Responsibilities:

    1. Regulatory Planning

    • Regulatory Plan Development: Create and recommend optimal regulatory strategies for product submissions, ensuring alignment with local regulations and business objectives.
    • Process Management: Coordinate with cross-functional teams (R&D, Marketing, Legal) for the timely preparation of regulatory documents.
    • Regulatory Tools: Ensure accurate and timely updates of regulatory data across tools, ensuring effective communication with stakeholders.

    2. Submissions and Approvals

    • Dossier Preparation: Prepare regulatory dossiers and submit them according to affiliate timelines.
    • Regulatory Approval: Secure approval from regulatory authorities, ensuring product registrations and launches meet affiliate plans.
    • Metrics Review: Track and report on submission and approval statuses, providing insights to management.

    3. Regulatory Compliance

    • Compliance Maintenance: Monitor and maintain compliance with all regulatory requirements, including labeling, manufacturing, and pharmacovigilance activities.
    • Good Regulatory Practices (GRP): Implement and update SOPs in line with global regulatory policies and local regulations.

    4. Regulatory Influence

    • External Relations: Build strong relationships with key regulatory officials and industry bodies to foster a positive regulatory environment.
    • Regulatory Environment Changes: Stay informed about changes in local and global regulations and communicate impacts to relevant stakeholders.

    5. Additional Responsibilities (if applicable)

    • Support regulatory pricing negotiations, clinical trial approvals, and the development of local product information.
    • Ensure accurate product information submission to local health authorities and facilitate packaging updates.

    Minimum Qualification Requirements:

    • B.Pharm, M.Pharm, BSc/Master’s in Chemistry, Biotechnology, or related fields, or MD.
    • At least 3 years of regulatory affairs or related experience.
    • In-depth knowledge of local and global pharmaceutical product registration processes.
    • Strong understanding of regulatory compliance and the business decision-making process.

    Additional Preferences:

    • Proficiency in English (both written and spoken). Additional languages are a plus.
    • Strong project management and communication skills.
    • Ability to navigate multi-tasking and work under tight deadlines.
    • Creative problem-solving and strong customer focus.

    Lilly is committed to providing equal opportunities and support for individuals with disabilities during the recruitment process. If you require accommodation to apply, please complete the accommodation request form here.

    Lilly does not discriminate on the basis of age, race, religion, gender, sexual orientation, or other legally protected status.

    #WeAreLilly

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