Senior Director, CMC Regulatory Affairs (Small Molecules)

Doist; Boston (MA); Hybrid; USD 242,000 - 314,000; Full time

Benefits offered by this job

Hybrid schedule

Equity eligibility

Comprehensive benefits

Job summary

Beeline Medicines in the United States is seeking a Senior Director, Regulatory Affairs CMC – Small Molecules to lead regulatory strategy for all CMC activities across the immunology and inflammation portfolio. You will shape global regulatory submissions, oversee IND/CTA through NDA, and partner with Process Chemistry, Analytical Sciences, Quality, and external CMOs to ensure FDA/EMA alignment.

The role is hybrid with two on-site days weekly and requires strong leadership, HA interactions, and

Qualifications

• Advanced degree in organic chemistry, pharmaceutical sciences, analytical chemistry or related small molecule discipline.
• Minimum 12+ years of CMC regulatory affairs experience in pharma/biotech.
• Deep expertise in small molecule CMC regulatory strategy and global submissions.

Responsibilities

• Lead the CMC regulatory strategy for all small molecule assets from IND/CTA through NDA and post‑approval lifecycle.
• Prepare and oversee CMC sections of global regulatory submissions (INDs, CTAs, NDAs, MAAs, variations) with high quality and defensibility.
• Lead Health Authority interactions (FDA/EMA) and coordinate responses to CMC deficiency letters and information requests.
• Provide regulatory interpretation of FDA, EMA and ICH CMC guidance and advise development teams on design space, process validation, and control strategy acceptability.

Education

Advanced degree (PhD/MS/PharmD)

Job description

Beeline Medicines in the United States is seeking a Senior Director, Regulatory Affairs CMC – Small Molecules to lead regulatory strategy for all CMC activities across the immunology and inflammation portfolio. You will shape global regulatory submissions, oversee IND/CTA through NDA, and partner with Process Chemistry, Analytical Sciences, Quality, and external CMOs to ensure FDA/EMA alignment.

The role is hybrid with two on-site days weekly and requires strong leadership, HA interactions, and