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    Associate Director - Regulatory Affairs And Liaisoning

    Eli Lily
    8+ 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: Associate Director - Regulatory Affairs and Liaisoning
    Location: Gurgaon, Haryana, India
    Category: Research & Development
    Job Type: Full-Time, Regular
    Job ID: R-72431

    About Eli Lilly:

    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 discover and deliver life-changing medicines. We also focus on improving the understanding and management of disease, alongside philanthropy and community service. Our commitment to making life better for patients around the world is at the heart of everything we do.

    Job Summary:

    The Associate Director - Regulatory Affairs and Liaisoning will manage and coordinate regulatory activities with key regulatory bodies in India. This includes liaising with the Central Drugs Standard Control Organization (CDSCO), Ministry of Health and Family Welfare (MoHFW), National Institute of Biologicals (NIB), Indian Pharmacopoeia Commission (IPC), and other relevant government authorities at both central and state levels. The role is responsible for ensuring compliance with local regulations, facilitating effective communication with regulatory bodies, and supporting the registration and maintenance of pharmaceutical products.

    Key Responsibilities:

    • Regulatory Compliance: Ensure all regulatory activities adhere to local regulations and guidelines set by CDSCO, MoHFW, NIB, IPC Ghaziabad, CDTL, and other authorities.
    • Liaison with Regulatory Bodies: Act as the primary point of contact between the company and regulatory authorities, ensuring smooth communication and addressing regulatory queries or issues.
    • Product Registration: Oversee the registration process for new products, line extensions, and new indications, ensuring timely submission and approval of regulatory dossiers.
    • Documentation: Prepare, review, and submit regulatory documents, including applications, variations, renewals, and responses to regulatory authorities.
    • Regulatory Strategy: Develop and implement regulatory strategies to support the company’s business objectives and ensure successful product registrations.
    • Cross-functional Collaboration: Work closely with internal departments, including R&D, Quality Assurance, and Marketing, to ensure alignment on regulatory requirements and timelines.
    • Regulatory Intelligence: Monitor and analyze changes in regulatory policies and guidelines, providing updates and recommendations to the management team, and maintaining related repositories.
    • Training and Development: Provide training and guidance to internal teams on regulatory requirements and best practices.
    • Stakeholder Management: Build and maintain relationships with key stakeholders, including government officials, industry associations, and other relevant entities.
    • Risk Management: Identify potential regulatory risks and develop strategies to mitigate those risks, ensuring compliance and minimizing operational impact.

    Qualifications:

    • Education: Bachelor’s degree in Pharmacy, Life Sciences, or a related field. Advanced degree preferred.
    • Experience: Minimum of 8 years of experience in regulatory affairs within the pharmaceutical industry, preferably in a multinational corporation (MNC).
    • Knowledge: In-depth knowledge of Indian regulatory requirements and guidelines, particularly those of CDSCO, MoHFW, NIB, IPC Ghaziabad, CDTL, and other relevant authorities.
    • Skills:
      • Strong communication and interpersonal skills, with the ability to build and maintain relationships with regulatory authorities.
      • Excellent organizational and project management skills, with the ability to manage 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 requirements and guidelines.
    • Strong analytical and problem-solving skills.
    • Ability to work independently and as part of a team.

    Why Join Us?

    Lilly is committed to creating an inclusive workplace, where all employees feel valued and respected. We offer a comprehensive benefits package, along with opportunities for career development and growth.

    Equal Opportunity:

    Lilly is dedicated to ensuring equal opportunities for individuals with disabilities. If you require accommodation to submit a resume, please complete the accommodation request form here.

    Lilly is an Equal Employment Opportunity/Affirmative Action Employer and 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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