Senior Director, Regulatory Affairs CMC – Small Molecule

BioSpace; Boston (MA); Hybrid; USD 180,000 - 260,000; Full time

Job summary

Beeline Medicines in Massachusetts is seeking a Senior Director, Regulatory Affairs CMC – Small Molecules to lead all CMC activities from IND/CTA through NDA and post‑approval lifecycle. You will partner with Technical Development, Process Chemistry, Analytical Sciences, Quality, and external CMOs to ensure compliant submissions and robust CMC strategies.

You will shape regulatory strategy, manage Health Authority interactions (FDA/EMA), oversee submissions in ICH CTD format, mentor teams, and

Qualifications

• Senior regulatory leadership experience in CMC for small molecules.
• Experience leading global submissions (IND/CTA through NDA).
• Strong collaboration with Development, QA, and external CMOs.

Responsibilities

• Lead CMC regulatory strategy for small molecule assets.
• Oversee global regulatory submissions in CTD/eCTD format.
• Manage Health Authority interactions (FDA/EMA).
• Coordinate with Process Development, Analytical, Manufacturing Sciences, and Quality.
• Mentor and align cross-functional teams on regulatory requirements.

Skills

CMC regulatory leadership

Regulatory strategy

FDA/EMA experience

ICH CTD

Cross-functional leadership

Tools

eCTD submissions

Job description

About Beeline Medicines

Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world‑class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully.

About Beeline Medicines

Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world‑class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully.

Job Summary

The Senior Director, Regulatory Affairs CMC – Small Molecules provides senior-level scientific and strategic regulatory leadership for all Chemistry, Manufacturing, and Controls (CMC) activities related to the company's small molecule assets within the immunology and inflammation (I&I) portfolio. This role is responsible for developing and executing CMC regulatory strategies from early clinical development through NDA filing and post-approval lifecycle management, serving as the company's foremost authority on small molecule CMC regulatory science. The Senior Director partners with Technical Development, Process Chemistry, Analytical Sciences, Quality, and external CMOs to ensure that CMC programs are designed, documented, and submitted in full alignment with FDA, EMA, and global Health Authority expectations. As a senior leader within the Regulatory Affairs organization, this individual also contributes to the broader regulatory strategy, and plays a key role in shaping the company's regulatory affairs infrastructure.

Work Arrangement & Location

Hybrid - This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week — currently designated as Tuesday and Wednesday. Additional on-site days may be required based on business needs, team priorities, or leadership direction.

Essential Duties And Responsibilities

• Develop and lead the CMC regulatory strategy for all small molecule assets in the I&I portfolio, from IND/CTA through NDA filing, including post-approval lifecycle management and labeling strategy for drug substance and drug product.
• Author, review, and oversee the preparation of CMC sections of global regulatory submissions in ICH CTD format, including INDs, CTAs, NDAs, MAAs, Type II variations, and supplements, with accountability for quality, completeness, and regulatory defensibility.
• Serve as the company's primary regulatory authority and strategic partner for small molecule Technical Development, Process Chemistry, Analytical Development, Formulation Sciences, and Quality functions on all CMC regulatory matters.
• Lead Health Authority interactions related to small molecule CMC topics, including FDA Type B and Type C meetings, EMA Scientific Advice meetings, and written responses to CMC deficiency letters and information requests from global regulatory agencies.
• Provide expert regulatory interpretation of FDA, EMA, and ICH CMC guidance documents applicable to small molecules, including ICH Q8, Q9, Q10, Q11, and Q12, and proactively advise development teams on design space, process validation, and control strategy regulatory acceptability.
• Lead post-approval CMC change management strategy for small molecule programs, including SUPAC assessments, Prior Approval Supplements (PAS), Changes Being Effected (CBE) filings, and ex‑US variation submissions.
• Oversee regulatory aspects of small molecule technology transfer activities, including new CMO onboarding, site-to-site comparability, and associated regulatory filing updates.
• Establish and maintain CMC regulatory SOPs, templates, and document management workflows specific to small molecule programs, ensuring compliance with ICH CTD, eCTD, and applicable electronic submission requirements.
• Contribute to regulatory due diligence evaluations of small molecule licensing candidates or acquisition targets, providing CMC regulatory risk assessment and readiness analysis.
• Tracks CMC regulatory deliverables and submission timelines across all small molecule programs, ensuring proactive identification of dependencies, risks, and upcoming milestones to keep cross-functional teams aligned and submission-ready.
• Act as a fully integrated partner within the CMC team, attending key technical meetings, engaging daily with Process Development, Analytical, Manufacturing Sciences, Drug Supply and Quality colleagues, and translating regulatory strategy into practical guidance that enables the CMC team to make informed decisions and move programs forward with regulatory confidence.
• Demonstrate entrepreneurial drive and resourcefulness in executing CMC regulatory responsibilities — proactively