Job Description:
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* This role is responsible for leading the CMC submission management process, ensuring compliance with global regulatory requirements.
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Key Responsibilities:
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1. Provide knowledge of CMC regulatory requirements, including ICH CTD and evolving global agency standards, to support clinical studies and manufacturing process changes.
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2. Partner with CMC RA Scientists to plan and prepare submission content, drive execution of submission planning, and implement global regulations and guidance.
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3. Triage Lilly affiliate inquiries and requests, consult with CMC RA Scientist as necessary, and provide responses to questions.
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4. Implement and interpret global regulations and guidance, publishing standards to ensure final document content and structure align with local regulatory requirements.
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Requirements:
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* Bachelor's Degree in a scientific or health sciences discipline (e.g., pharmacy, chemistry, or related scientific discipline).
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* Knowledge of pharmaceutical drug development or industry-related experience preferred.
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* Ability to operate and manage operational requirements in a regulated environment.
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* Written, spoken, and presentation skills; negotiation and influence skills; attention to detail and ability to effectively prioritize.
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Benefits:
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* We are committed to helping individuals with disabilities participate in the workforce and ensure equal opportunity to compete for jobs.
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* Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.
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