Senior Director, Small Molecule CMC Regulatory Strategy

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

Job summary

Beeline Medicines, a US-based biotechnology company focused on autoimmune and inflammatory diseases, seeks a Senior Director, Regulatory Affairs CMC – Small Molecules to lead regulatory strategy for its small molecule assets from early development through NDA and post‑approval lifecycle.

This role partners with Technical Development, Process Chemistry, Analytical Sciences, Quality, and external CMOs to ensure submissions align with FDA, EMA, and global Health Authority expectations.

Qualifications

• Lead CMC regulatory strategy for small molecule assets from IND/CTA through NDA.
• Author and oversee CMC sections of global regulatory submissions.
• Lead Health Authority meetings with FDA/EMA.
• Mentor cross-functional teams and ensure regulatory compliance.
• Maintain CTD/eCTD documentation and SOPs.

Responsibilities

• Develop and lead the CMC regulatory strategy for IND/CTA through NDA and post-approval lifecycle management.
• Author, review, and oversee CMC sections of global regulatory submissions in ICH CTD/eCTD format.
• Serve as primary regulatory partner for cross-functional teams on all CMC matters.
• Lead FDA/EMA meetings and respond to CMC deficiency letters and information requests.
• Maintain CMC SOPs, templates, and document management workflows.

Skills

CMC regulatory strategy

Health Authority interactions

Regulatory submissions

Cross-functional leadership

Regulatory guidance

Education

Advanced degree (PhD/MS/PharmD)

Job description

Beeline Medicines, a US-based biotechnology company focused on autoimmune and inflammatory diseases, seeks a Senior Director, Regulatory Affairs CMC – Small Molecules to lead regulatory strategy for its small molecule assets from early development through NDA and post‑approval lifecycle.

This role partners with Technical Development, Process Chemistry, Analytical Sciences, Quality, and external CMOs to ensure submissions align with FDA, EMA, and global Health Authority expectations.