Senior Director, Small Molecule CMC Regulatory Affairs – Remote

Beeline Medicines; United States; Remote; USD 180,000 - 260,000; Full time

Job summary

Beeline Medicines is seeking a Senior Director, Regulatory Affairs CMC to provide senior scientific and strategic regulatory leadership for all CMC activities across the immunology and inflammation portfolio. You will develop and execute regulatory strategies from early development through NDA filing and post‑approval lifecycle management.

You will partner with Technical Development, Process Chemistry, Analytical Sciences, Quality, and CMOs to ensure alignment with FDA, EMA, and global Health

Qualifications

• Advanced degree in organic chemistry, pharmaceutical sciences, analytical chemistry, or related field preferred.
• Minimum 12+ years of CMC regulatory affairs experience in pharma/biotech.
• Hands-on CMC regulatory experience required; biologics CMC experience is a plus.
• Expert knowledge of ICH Q8/Q9/Q10/Q11/Q12 and related regulatory guidance.

Responsibilities

• Develop and lead CMC regulatory strategy for small molecule assets from IND/CTA through NDA and post-approval changes.
• Prepare and oversee CMC sections of global regulatory submissions (INDs, CTAs, NDAs, MAAs, variations).
• Lead Health Authority interactions (FDA/EMA) on CMC topics and respond to deficiency letters.
• Guide process development, analytical development, formulation, and quality teams on regulatory expectations.
• Manage post-approval CMC changes, SUPAC, PAS/CBE, and ex-US variations.

Education

Advanced degree (PhD, MS, or PharmD) in organic chemistry or pharmaceutical sciences

12+ years of CMC regulatory affairs experience

Experience leading FDA/EMA Health Authority meetings

Strong regulatory strategy and submission experience (ICH CTD/eCTD)

Job description

Beeline Medicines is seeking a Senior Director, Regulatory Affairs CMC to provide senior scientific and strategic regulatory leadership for all CMC activities across the immunology and inflammation portfolio. You will develop and execute regulatory strategies from early development through NDA filing and post‑approval lifecycle management.

You will partner with Technical Development, Process Chemistry, Analytical Sciences, Quality, and CMOs to ensure alignment with FDA, EMA, and global Health