Advisor/Senior Advisor Global Regulatory Affairs CMC – Post Approval – Synthetic Molecule Drug Substances

Role Summary

Advisor/Senior Advisor Global Regulatory Affairs CMC – Post Approval – Synthetic Molecule Drug Substances. Lilly is seeking post-approval regulatory CMC scientists to drive regulatory CMC strategies and lifecycle submissions for Lilly’s commercial products, leveraging CMC technical knowledge and regulatory science expertise to support product lifecycles.

Responsibilities

• Deep technical knowledge of synthetic molecule drug substance CMC science and manufacturing processes for conventional small molecules and/or synthetic peptides, proteins, or oligonucleotides.
• Knowledge of global CMC regulatory requirements and guidelines for reporting post-approval changes and updating global product registrations.
• Develop and evaluate global CMC regulatory strategies in collaboration with Regulatory, Manufacturing, Quality, and project teams to enable timely submission milestones leading to approval.
• Develop regulatory strategy and update strategy based on global regulatory changes.
• Provide regulatory guidance to allow CMC teams to make informed decisions on global registrations and product lifecycle planning.
• Anticipate and resolve key technical or operational issues that could impact the function, CMC team, or submission timing.
• Lead and independently manage challenging projects, identifying creative solutions that support functional and partner organization requirements.
• Lead the critical review of molecule-specific CMC development strategies and submission content for registration, post-approval changes, line extensions or renewals, and responses to questions.
• Make decisions on CMC regulatory strategies impacting product submissions across geographies for alignment with CMC team members.

Qualifications

• Required: B.S. degree in a science, engineering, or related field (Chemistry, Pharmacy or Pharmaceutics, Chemical Engineering, Analytical Sciences, Biology, Biochemistry, or similar).
• Required: 7+ years of regulatory CMC or technical CMC experience in synthetic molecule drug substance development, commercialization, or manufacturing.
• Preferred: Demonstrated deep technical knowledge and experience of synthetic molecule drug substance development, commercialization, and manufacturing processes, including conventional small molecules and/or synthetic peptides, proteins, or oligonucleotides.
• Preferred: Prior regulatory CMC experience supporting commercialization and/or post-approval submissions for synthetic drug substances, or equivalent combination of technical and regulatory guidance knowledge.
• Preferred: Knowledge of major market procedures, regulations, and practices; awareness of evolving global regulatory initiatives.
• Preferred: Experience planning for and/or participating in Health Authority meetings.
• Preferred: Ability to assess and manage risk in a highly regulated environment.
• Preferred: Strong written, spoken, and presentation communication skills.
• Preferred: Leadership, negotiation, and influence skills; attention to detail; teamwork and adaptability to diverse interpersonal styles.

Skills

• Regulatory strategy and dossier development
• CMC regulatory knowledge for post-approval changes and lifecycle management
• Cross-functional collaboration with Regulatory, Manufacturing, and Quality
• Risk assessment and issue resolution in regulated environments
• Effective written and verbal communication; presentations

Education

• B.S. in science, engineering, or a related field as listed in Qualifications

Additional Requirements

• Position Location: Indianapolis, IN. Remote option not available.
• Travel: Minimal within the US.