Regulatory Starting Materials Strategy Lead

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 126,000 - 268,000; Full time

Benefits offered by this job

Bonus program

401(k) plan

Medical/dental/vision insurance

Vacation benefits

Well-being program

Job summary

Lilly in the US is seeking an Associate Director, Regulatory Starting Material to lead strategy, justification, and regulatory positioning of RSM for drug substance manufacturing supporting late-stage programs. You will partner with multiple functions to ensure scientifically sound and regulatorily defensible material design and readiness for commercial manufacturing.

The role requires PhD preferred and 7+ years in CMC or drug substance development with strong writing and leadership skills.

Qualifications

• Experience leading regulatory strategy for drug substance starting materials.
• Authoring and defending CMC regulatory submissions and health authority interactions.
• Deep knowledge of ICH Q11 and regional guidance for starting materials.
• Leadership of cross-functional teams in late-stage programs.
• Experience with CMOs and supplier management.
• Strong technical writing and communication skills.

Responsibilities

• Lead regulatory strategy for Regulatory Starting Materials across routes.
• Manage resupply, scale-up, inventory, and scheduling with CMOs.
• Prepare and defend CMC submissions (Module 3, briefing docs, responses).
• Lead health authority meetings and prepare briefing packages.
• Collaborate with Process Chemistry, Analytical Development, Regulatory Affairs, QA.
• Define GMP/non-GMP boundaries for drug substance processes.
• Oversee technology transfer and changes affecting RSM designation.
• Manage relationships with CMOs and RSM suppliers.
• Monitor regulatory guidance and update internal templates and risk assessments.
• Support cross-functional program timelines and supply continuity.

Education

PhD preferred

Advanced degree in chemistry/related field

Job description

Lilly in the US is seeking an Associate Director, Regulatory Starting Material to lead strategy, justification, and regulatory positioning of RSM for drug substance manufacturing supporting late-stage programs. You will partner with multiple functions to ensure scientifically sound and regulatorily defensible material design and readiness for commercial manufacturing.

The role requires PhD preferred and 7+ years in CMC or drug substance development with strong writing and leadership skills.