Senior Director, Regulatory Affairs CMC

The role

Lead the CMC regulatory strategy for small molecule immunology and inflammation assets, from IND or CTA through NDA filing and post-approval changes. Author and oversee CMC sections of global regulatory submissions and lead Health Authority interactions with FDA and EMA.

What you will do

• Develop and lead the CMC regulatory strategy for all small molecule assets in the immunology and inflammation portfolio, from IND/CTA through NDA filing, including post-approval lifecycle and labeling
• Author, review and oversee CMC sections of global regulatory submissions in ICH CTD format, including INDs, CTAs, NDAs, MAAs, Type II variations and supplements.
• Serve as the primary regulatory authority and strategic partner for Technical Development, Process Chemistry, Analytical Development, Formulation Sciences and Quality on CMC regulatory matters.
• Lead Health Authority interactions on small molecule CMC topics, including FDA Type B and Type C meetings, EMA Scientific Advice meetings and responses to CMC deficiency letters.
• Provide regulatory interpretation of FDA, EMA and ICH CMC guidance, including ICH Q8 through Q12, and advise teams on design space, process validation and control strategy.
• Lead post-approval CMC change management, including SUPAC assessments, Prior Approval Supplements, Changes Being Effected filings and ex-US variations.
• Oversee regulatory aspects of technology transfer, new CMO onboarding and site-to-site comparability.
• Establish and maintain CMC regulatory SOPs, templates and document management workflows for small molecule programs.
• Contribute regulatory due diligence and CMC risk assessment for licensing candidates or acquisition targets.
• Track CMC regulatory deliverables and submission timelines across programs and identify dependencies and risks.

Required qualifications

• Advanced degree (PhD, MS or PharmD) in organic chemistry, pharmaceutical sciences, analytical chemistry or a related small molecule-relevant discipline.
• Minimum of 12 years of CMC regulatory affairs experience in the pharmaceutical or biotech industry.
• Hands-on small molecule CMC regulatory experience.
• Deep expertise in small molecule CMC regulatory strategy, including drug substance synthesis and control, drug product formulation and manufacturing, and analytical method development and validation.
• Extensive experience authoring and overseeing small molecule CMC sections of global submissions in ICH CTD/eCTD format.
• Demonstrated track record of leading FDA and EMA CMC-focused Health Authority meetings and managing written responses to deficiency letters.
• Comprehensive knowledge of ICH Q8, Q9, Q10, Q11 and Q12, FDA small molecule CMC guidance (e.g., SUPAC) and EMA quality guidance.
• Proven experience managing CMC regulatory aspects of technology transfer, new CMO qualification and site change filings.
• Strong command of post-approval change regulations, including SUPAC categories, PAS/CBE requirements and ex-US variation frameworks.
• Ability to lead and develop cross-functional teams in a fast-paced, resource-constrained environment.
• Proven track record of influencing without authority and building consensus among senior stakeholders.
• Experience navigating ambiguity and change and scaling functional capabilities.

Nice to have

• Advanced degree in organic chemistry, pharmaceutical sciences, analytical chemistry or a related discipline (strongly preferred).
• Minimum of 12 years of CMC regulatory affairs experience (preferred).
• Experience with biologics CMC regulatory strategy, such as monoclonal antibodies or recombinant proteins (highly preferred, not required).

Benefits

• Competitive health and wellness coverage (structure and premiums vary by country)
• Paid time off, public holidays and additional leave in accordance with local requirements
• Flexible work arrangements and hybrid schedule
• Discretionary annual bonus and long-term incentive award (e.g., equity), based on individual and company performance

Before you apply

• Massachusetts law prohibits requiring a lie detector test as a condition of employment.

About the company

Beeline Medicines is a clinical-stage biotechnology company developing precision therapies for autoimmune and inflammatory diseases. It is backed by life science investors and led by an established executive team.