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    Manager / Senior Manager - Regulatory Affairs

    Lilly
    0-2 years
    Not Disclosed
    Gurgaon India
    10 Feb. 11, 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

    Job Title: Manager/Sr. Manager - Regulatory Affairs
    Location: Gurgaon, Haryana, India
    Category: Research & Development
    Job Type: Full Time, Regular
    Job ID: R-72432

    Purpose:

    The role of Manager/Sr. Manager in Regulatory Affairs is pivotal in ensuring the effective regulatory planning and compliance for new product registrations, product line extensions, and new indications within the affiliate and responsible countries. The position involves preparing submissions, gaining approvals for new products, and ensuring ongoing regulatory compliance for marketed products. This role also requires building strong relationships with regulatory authorities and staying up-to-date on evolving local and global regulations.

    Primary Responsibilities:

    1. Regulatory Planning:

      • Develop regulatory plans for assigned products, ensuring alignment with product teams, business strategies, and country-specific requirements.
      • Review and recommend regulatory strategies for pipeline products, considering regulatory timelines and processes.

    2. Process Management:

      • Coordinate with cross-functional teams to ensure timely availability of documents and other requirements for dossier preparation.
      • Provide regulatory expertise to cross-functional teams to ensure adherence to regulatory timelines.

    3. Regulatory Tools:

      • Ensure timely updating of data in regulatory tools to maintain global process standards and communicate status to relevant stakeholders.

    4. Submissions and Approvals:

      • Prepare quality regulatory dossiers and submit within planned timelines.
      • Respond to regulatory authorities (e.g., Ministry of Health) to secure approvals for product launches.
      • Track and archive submissions, approvals, and post-approval commitments.
      • Support packaging development to ensure compliance with local and corporate standards.

    5. Regulatory Compliance:

      • Maintain regulatory compliance for marketed products, ensuring timely management of labeling and packaging changes, and handling pharmacovigilance activities.
      • Conduct periodic compliance audits to identify and address issues, taking corrective actions when necessary.

    6. Regulatory Influence:

      • Establish and maintain strong relationships with key regulatory officials to influence the regulatory environment and support business operations.
      • Stay informed about changes in local and global regulatory requirements and their impact on business strategies.
      • Support the development and implementation of external regulatory strategies.

    7. Internal Collaboration and Communication:

      • Partner with the affiliate organization to support business decisions and communicate the value of regulatory affairs in driving the business forward.
      • Utilize regulatory tools to inform affiliate business partners about the status of new products and local regulatory trends.

    8. Additional Responsibilities (if applicable):

      • Provide regulatory support for locally manufactured products and clinical trials.
      • Ensure all aspects of packaging and product information meet regulatory requirements.

    Minimum Qualification Requirements:

    • Education:

      • B.Pharm, M.Pharm, BSc, or Master’s Degree in Chemistry, Biotechnology, or related fields; or MD (if licensed in the country).

    • Experience:

      • Minimum of 3 years of experience in regulatory affairs or related fields.
      • In-depth knowledge of local regulations and product registration requirements for pharmaceutical products and devices.

    • Skills:

      • Competent project management skills.
      • Strong communication, interpersonal, and negotiation skills.
      • Ability to manage multiple tasks effectively.
      • Analytical skills with a focus on accuracy and reliability.

    Additional Preferences:

    • Broad understanding of Lilly’s goals and objectives.
    • Good knowledge of written and spoken English (additional languages are beneficial).
    • Strong creative thinking and problem-solving abilities.
    • Customer-focused approach to regulatory practices.

    Other Information:

    • Location: Gurgaon, Haryana
    • Lilly’s Commitment: Lilly is dedicated to ensuring equal opportunities for individuals with disabilities and offers reasonable accommodations during the application process.
    • Equal Opportunity Employer: Lilly does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.

    #WeAreLilly

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