Associate Director, Regulatory Starting Materials Strategy

BioSpace; Indianapolis (IN); On-site; USD 126,000 - 268,000; Full time

Benefits offered by this job

Company bonus

401(k) plan

Medical, dental, vision benefits

Pension

Job summary

Lilly, headquartered in Indianapolis, Indiana, seeks an Associate Director for Regulatory Starting Material. This role leads RSM strategy for drug substance manufacturing, partners with Process Chemistry, Analytical Development, and Regulatory Affairs, and interacts with health authorities. Requires PhD/advanced degree and 7+ years in CMC/regulatory roles.

Based in the US with ~10–20% travel. Competitive benefits and bonus eligible.

Qualifications

• PhD or advanced degree in chemistry or related field required.
• 7+ years in CMC, process chemistry or API development/manufacturing.
• Experience supporting late-stage clinical or commercial drug substance programs.
• Deep knowledge of ICH Q11 and regional guidance.
• Experience authoring CMC regulatory submissions and health authority interactions.
• Leadership of material strategy and cross-functional collaboration.

Responsibilities

• Lead regulatory strategy for Regulatory Starting Materials across drug substance routes.
• Manage starting material resupply campaigns, inventory and forecasting.
• Author/review CMC submission content related to RSM selection/justification.
• Lead health authority interactions and briefing packages.
• Collaborate with Process Chemistry and Analytical Development.
• Define boundary between non-GMP and GMP steps for drug substance processes.
• Lead tech transfer and process changes affecting RSM designation.
• Manage relationships with CMOs and RSM suppliers.
• Monitor global guidance and update internal strategy/templates.
• Collaborate with Regulatory Affairs, Quality, Supply Chain, and Manufacturing.
• Support due diligence activities for licensing/partnerships.
• Provide SME during regulatory inspections/audits.
• Build/mentor a team for RSM/CMC strategy.
• Domestic/international travel 10–20%.

Skills

Leadership

Cross-functional collaboration

Scientific writing

Regulatory strategy

Regulatory submissions

Education

Advanced degree in chemistry/related field

PhD strongly preferred

Tools

None

Job description

Lilly, headquartered in Indianapolis, Indiana, seeks an Associate Director for Regulatory Starting Material. This role leads RSM strategy for drug substance manufacturing, partners with Process Chemistry, Analytical Development, and Regulatory Affairs, and interacts with health authorities. Requires PhD/advanced degree and 7+ years in CMC/regulatory roles.

Based in the US with ~10–20% travel. Competitive benefits and bonus eligible.