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. The role focuses on leveraging CMC technical knowledge and regulatory science to drive post-approval and lifecycle regulatory strategies and submissions for Lilly’s commercial products, with an emphasis on synthetic molecule drug substances.

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.
• Develops and evaluates global CMC regulatory strategies in collaboration with regulatory, Manufacturing, Quality and project personnel to enable timely completion of submission milestones leading to health authority approval.
• Development of regulatory strategy and update strategy based upon global regulatory changes.
• Provide regulatory guidance to allow CMC teams to make informed decisions on global registrations and product lifecycle planning.
• Anticipates and resolves key technical or operational issues that could impact the function, CMC team and/or submission timing.
• Takes on and independently manages challenging projects and identifies creative solutions that support functional and partners organization requirements.
• Leads critical review of molecule-specific CMC development strategies and submission content for registration, post-approval changes, line extensions or renewals, and responses to questions.
• Makes decisions on CMC regulatory strategies impacting product submissions across geographies and networks in alignment with CMC team members.

Qualifications

• B.S. degree in a science, engineering, or related field (Chemistry, Pharmacy/Pharmaceutics, Chemical Engineering, Analytical Sciences, Biology, Biochemistry, or similar).
• 7+ years of regulatory CMC or technical CMC experience in synthetic molecule drug substance development, commercialization or manufacturing.
• Demonstrated ability to assess and handle risk in a highly regulated environment.

Skills

• Deep technical knowledge of synthetic molecule drug substance development, commercialization and manufacturing processes for conventional small molecules and/or synthetic peptides, proteins or oligonucleotides.
• Prior regulatory CMC experience supporting commercialization and/or post-approval submissions for synthetic drug substances.
• Knowledge of major market procedures, regulations, and practices; awareness of evolving global regulatory initiatives.
• Experience planning for and/or participating in Health Authority meetings.
• Strong written, verbal, and presentation communication skills; leadership, negotiation and influence skills; attention to detail; and teamwork.

Education

• B.S. degree in science/engineering or related field as specified above.

Additional Requirements

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