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    Sr. Scientist, Principal Scientist, Sr. Principal Scientist, Advisor, Sr. Advisor – Gra-Cmc-Asia Pacific

    Eli Lily
    4-7 years
    Not Disclosed
    Singapore
    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: Sr. Scientist, Principal Scientist, Sr. Principal Scientist, Advisor, Sr. Advisor – GRA-CMC-Asia Pacific

    Location: Immunos, Singapore

    Category: Research & Development

    Job Type: Full Time, Regular

    Job ID: R-70559

    Company Overview

    At Lilly, we unite caring with discovery to make life better for people around the world. As a global healthcare leader, we are headquartered in Indianapolis, Indiana, and have a presence across the globe. Our team is dedicated to discovering, developing, and delivering life-changing medicines to help improve the health of communities worldwide. We also give back through philanthropy and volunteerism, striving to improve lives beyond just medical innovation.

    Role Purpose

    The GRA-CMC-Asia Pacific role focuses on providing strategic, tactical, and operational leadership to accelerate the Chemistry, Manufacturing, and Controls (CMC) development of Lilly's product portfolio within the Asia Pacific (AP) region, including Japan, China, Australia, New Zealand, Korea, Taiwan, Singapore, ASEAN Alliance, and India. The role involves developing successful regulatory strategies for market registrations and lifecycle maintenance by leveraging strong knowledge of global regulatory frameworks and CMC development processes.

    Key Responsibilities

    Regulatory & Scientific Expertise

    • Lead the development of regulatory strategies and update them based on evolving regulations across the AP region.
    • Provide high-quality, timely regulatory advice to CMC teams for well-informed decision-making on development and lifecycle planning.
    • Review CMC documents for AP region submissions, collaborating with GRA-CMC and manufacturing site regulatory scientists to assess manufacturing changes, new products, or line extensions.
    • Assess and resolve key technical or operational issues impacting CMC teams and regulatory functions.
    • Conduct risk-benefit analysis for regulatory compliance related to CMC activities.
    • Stay current with evolving regulations and incorporate new guidance into GRA-CMC processes.

    Influence & Strategy

    • Build and maintain strong relationships throughout Global Regulatory Affairs (GRA) and across Lilly’s functions to align on CMC regulatory strategies.
    • Provide regional guidance on CMC regulatory issues, promoting successful product registrations and regulatory compliance.
    • Influence internal policy development and participate in industry organizations to shape evolving regulatory positions in the AP region.

    Leadership, Collaboration & Partnering

    • Take a leadership role in preparing, reviewing, and finalizing CMC submission documents for product registrations and regulatory responses.
    • Collaborate with Japan, China, and AP-regional colleagues to ensure alignment on CMC strategies affecting product submissions.
    • Develop effective cross-functional relationships within Lilly’s departments to promote open discussions on regulatory issues and support drug development strategies.
    • Ensure timely submissions for the AP region, communicating effectively with stakeholders within work groups, development teams, and regulatory departments.

    Minimum Qualifications

    • Education: Bachelor's degree (BSc) in a biological or life science field (e.g., chemistry, biology, biochemistry, or pharmacy). An advanced degree (MSc, PhD, PharmD) is preferred.
    • Experience: Minimum of 4 years of experience in pharmaceutical industry technical drug development, regulatory affairs, or related field.
    • Regulatory CMC Experience: 4-7 years of regulatory CMC experience or a combination of technical and regulatory expertise.
    • Languages: Fluency in English and proficiency in one or more AP-regional languages is preferred.
    • Skills:
      • Strong written, verbal, and presentation communication skills.
      • Negotiation and influence skills, with attention to detail.
      • Demonstrated teamwork skills and adaptability to diverse interpersonal styles.

    Additional Preferences

    • Prior experience authoring CMC submission content.
    • Deep knowledge of AP-regional CMC regulatory requirements and guidelines for product registrations.
    • Ability to engage with regulatory agencies and influence strategic decisions.
    • Prior experience in cross-regional regulatory collaboration and leadership.

    Equal Opportunity Employer

    Lilly is committed to creating an inclusive workplace. We encourage individuals with disabilities to apply and provide accommodations for those who need assistance in the application process. Lilly does not discriminate based on race, age, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, disability, or any other legally protected status.

    #WeAreLilly 

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