LillyHiring

Senior Director, Regulatory CMC

  • Remote, United States
  • Lead
  • Posted 5 days ago
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In one line

Lead regulatory CMC strategy for small molecule programs at a clinical-stage drug developer, from early work through marketing applications; remote.

About the role

Fits someone with hands-on late-stage experience who can steer outsourced development and manufacturing partners and keep submissions on track. The role reports to an executive director and covers the whole portfolio.

At a glance

Pay
Not stated in the posting
Remote scope
Remote, United States
Seniority
Lead
Skills
Regulatory CMC, Small molecule development, IND, NDA, Drug substance, Drug product
Posted
24 Oct 2026
Last checked
29 Oct 2026

What you will do

  • Set and carry out CMC regulatory strategy for small molecule programs from preclinical work through late-stage trials and filings.
  • Guide drug substance, drug product, analytical work, manufacturing and controls across development and toward commercialization.
  • Act as the CMC expert on cross-functional program teams, keeping plans aligned with clinical, quality and business goals.
  • Lead preparation and review of CMC content for INDs, CTAs, marketing applications, variations and briefing packages.
  • Track changing global regulatory requirements and guidance and fold them into the work.

What they look for

  • Recent hands-on leadership of late-stage programs, NDA-enabling activities and marketing application submissions.
  • Strong expertise in outsourced development and manufacturing.

Nice to have

  • Broad lifecycle experience across development stages.

How Keywordise applies for you

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Claude

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Connector URL
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ChatGPT

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Connector URL
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Muse

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Message for Muse
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Muse is available in the US only for now.

Prompt
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How to connect

Questions about this job

Is this a remote job, and where can I work from?

Yes. The posting lists Senior Director, Regulatory CMC as a remote role for candidates in the United States.

What does this job pay?

No pay range is stated in the posting.

What experience is needed?

It is a lead role. The posting asks for: recent hands-on leadership of late-stage programs, NDA-enabling activities and marketing application submissions; strong expertise in outsourced development and manufacturing. Skills it names include Regulatory CMC, Small molecule development, IND, NDA.

How do I apply with Keywordise AI?

Press the Apply with Keywordise AI button and add your CV. Keywordise tailors your CV and cover letter to this posting and sends the application for you, with a free 7-day trial and no card.

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