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    Associate Director - Clinical Regulatory Scientist (Specializing In Pediatrics)

    Eli Lily
    5-8 years
    Not Disclosed
    Cork
    10 Jan. 31, 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 - Clinical Regulatory Scientist (Specializing in Pediatrics)
    Location: Cork, Cork, Ireland
    Category: Research & Development
    Job Type: Full-Time Regular
    Job Id: R-71384

    Company Overview:
    Eli Lilly is a global healthcare leader committed to making life better for people around the world. We work to discover and bring life-changing medicines to those who need them, improve disease understanding and management, and give back to communities through philanthropy and volunteerism. We are seeking individuals passionate about making a difference and dedicated to driving scientific innovation.

    At Eli Lilly Cork, our team of over 1,600 employees from 38 nationalities collaborate to deliver innovative solutions across multiple functions, including Finance, Information Technology, Medical, and Clinical Trials. We offer a premium workplace with flexible hybrid working options, healthcare benefits, subsidized canteen, gym, and other holistic benefits to support your career and wellbeing.

    Role Overview:
    As the Associate Director - Clinical Regulatory Scientist, specializing in Pediatrics, you will play a critical role in developing and executing regulatory strategies for pediatric drug products. You will lead the regulatory efforts for pediatric product development and support the US and Canada registration strategy, ensuring compliance with global standards while driving the market differentiation of Lilly's products.

    Primary Responsibilities:

    1. Regulatory and Scientific Expertise:

      • Develop, update, and execute US and Canada regulatory strategies for pediatric drug products.
      • Initiate and update regulatory strategy documents in collaboration with cross-functional teams.
      • Leverage regulatory feedback, competitor data, and industry trends to develop innovative strategies for pediatric drug development.
      • Ensure regulatory strategies align with global product development goals.
      • Collaborate with clinical and commercial teams to inform pricing, access strategies, and market differentiation.

    2. Labeling and Submission Strategy:

      • Drive the development and update of US and Canadian labeling strategies, including prescribing information, patient labeling, and device labeling.
      • Prepare and submit regulatory documents for IND, NDA/BLA, IDE, and other submissions related to pediatric drugs.
      • Monitor regulatory feedback and make necessary adjustments to labeling and claims.

    3. Stakeholder Management and Collaboration:

      • Partner with internal teams (e.g., regulatory, clinical, marketing, and commercial) to ensure seamless execution of regulatory strategies.
      • Cultivate relationships with FDA, Health Canada, and other regulatory authorities to support pediatric product development.
      • Lead discussions with global marketing and payer teams to ensure regulatory strategies are aligned with market needs.

    4. Market Differentiation and Risk Management:

      • Integrate innovative regulatory strategies and data to accelerate product development and enhance market differentiation.
      • Identify, assess, and mitigate regulatory risks that could impact product development or approval timelines.
      • Provide strategic regulatory advice to ensure market access and differentiation across key development milestones.

    5. Leadership and Teamwork:

      • Lead and influence cross-functional teams to ensure successful regulatory submissions and approvals for pediatric drug products.
      • Model Lilly’s values, fostering a culture of innovation, inclusion, and collaboration within the regulatory team.
      • Contribute to the development of team processes and best practices for regulatory submissions and strategy.

    Minimum Qualifications:

    • Bachelor’s degree in a scientific or health sciences discipline (PharmD, MD, or similar advanced degree preferred).
    • 5-8 years of experience in regulatory affairs or drug development, with a focus on pediatric products.
    • Knowledge of FDA and Health Canada regulatory processes, especially in the pediatric domain.
    • Strong understanding of the drug development process and regulatory requirements for pediatric products.
    • Experience in the development of regulatory strategy documents, labeling, and clinical submissions.
    • Proven ability to manage multiple projects and lead cross-functional teams.
    • Excellent communication, negotiation, and presentation skills.

    Additional Preferences:

    • Advanced degree (PhD, MD, PharmD, etc.) in relevant scientific or health discipline.
    • Experience with pediatric clinical trials and regulatory submissions related to pediatric products.
    • Deep knowledge of pediatric therapeutic areas, including but not limited to oncology, neurology, immunology, or endocrine disorders.
    • Demonstrated ability to work effectively in a global regulatory environment.
    • Strong problem-solving skills and the ability to develop innovative solutions to complex regulatory challenges.

    Travel: Expected 10-15%.

    Diversity, Equity, and Inclusion:
    Eli Lilly is committed to fostering a diverse and inclusive workforce, promoting equality and embracing diverse perspectives in all aspects of our business. We encourage candidates from all backgrounds to apply.

    To Apply:
    If you are passionate about pediatric regulatory science and want to make an impact on the development of breakthrough therapies, we encourage you to apply.

    Equal Opportunity Employer:
    Eli Lilly is an Equal Opportunity Employer, and we do not discriminate on the basis of age, race, color, religion, gender, gender identity, sexual orientation, national origin, disability, or any other legally protected status.

    #WeAreLilly

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