Director, Global Regulatory Affairs - Chemistry, Manufacturing and Controls; CMC), Platform Innovation - Molecules

Key Responsibilities

• Deep technical knowledge of small molecule CMC drug development and manufacturing sciences across modalities and platforms (drug substance, drug product, analytical sciences).
• Knowledge of global CMC regulatory requirements and guidelines for conducting clinical trials and obtaining/maintaining product registrations.
• Develop and implement regulatory strategies and platform approaches based on new guidance, evolving expectations, and regulatory precedent.
• Provide regulatory guidance to CMC development teams for development and product lifecycle planning.
• Lead preparation, critical review, and approval of CMC documents for global regulatory submissions (clinical trial applications, marketing applications, variations/supplements, and health authority information requests).
• Proactively lead critical review of molecule-specific CMC development and lifecycle strategies.
• Provide timely, clear regulatory advice to support informed project decisions.
• Make CMC regulatory strategy decisions impacting submissions across geographies/networks.

• B.S. in a science, engineering, or STEM field (advanced degree preferred); e.g., Chemistry, Pharmaceutics, Chemical Engineering, Analytical Sciences, Biology, or similar.
• 10+ years of Regulatory CMC or technical CMC experience supporting clinical development and/or commercialization of synthetic molecules.

• Authoring CMC submissions; involvement in clinical trial applications/marketing authorization processes and responses.
• Knowledge of major market procedures/regulations/practices; awareness of evolving initiatives.
• Experience with synthetic molecule drug substance/drug product development, commercialization, or manufacturing.
• Experience planning for/participating in Health Authority meetings.
• Risk assessment/management in highly regulated environments; strong communication and leadership/influence skills.

• Location:
  
  Indianapolis, IN (remote option may be considered); relocation assistance provided; minimal US travel.
• Compensation range: $148,500 - $257,400. Bonus eligibility and comprehensive benefits may apply.