Back to jobs
tags.new

Senior Director, Regulatory Affairs CMC – Small Molecule

Boston, Massachusetts, United States

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 seek out information, build relationships across the CMC organization, and find creative avenues to get things done; a successful CMC regulatory lead takes ownership of being plugged in, earns trust within the team, and removes barriers through initiative and ownership.
  • Perform other duties and responsibilities as assigned


Qualifications:

  • Education: Advanced degree (PhD, MS, or PharmD) in organic chemistry, pharmaceutical sciences, analytical chemistry, or a related small molecule-relevant discipline strongly preferred.
  • Minimum of 12+ years of CMC regulatory affairs experience in the pharmaceutical or biotech industry preferred
  • Deep and comprehensive expertise in small molecule CMC regulatory strategy, including drug substance (API) synthesis and control, drug product formulation and manufacturing, and analytical method development and validation for oral, parenteral, and other dosage forms.
  • Extensive experience authoring and overseeing small molecule CMC sections of global regulatory submissions, including INDs/CTAs, NDAs, MAAs, and post-approval supplements and variations in ICH CTD/eCTD format.
  • Demonstrated track record of leading FDA and EMA CMC-focused Health Authority meetings, including preparation of briefing documents and strategic management of written responses to CMC deficiency letters
  • Comprehensive knowledge of ICH Q8/Q9/Q10/Q11/Q12 guidelines, FDA small molecule CMC guidance documents (e.g., SUPAC, process validation, container closure), and EMA quality guidance applicable to small molecule chemical entities.
  • Proven experience managing CMC regulatory aspects of technology transfer, new CMO qualification, and site change regulatory filing strategies for small molecule programs.
  • Strong command of post-approval CMC change management regulations, including SUPAC categories, PAS/CBE filing requirements, and ex-US variation frameworks.
  • Demonstrated ability to lead and develop cross-functional teams in a fast-paced, resource-constrained biotech or pharmaceutical environment; fosters a culture of accountability, inclusion, and continuous learning.
  • Proven track record of influencing without authority across organizational boundaries, driving alignment among senior stakeholders, and building consensus on complex regulatory or scientific priorities.
  • Experience navigating organizational ambiguity and change; capable of defining structure, establishing priorities, and scaling functional capabilities in alignment with evolving corporate strategy.
  • Exceptional written and verbal communication skills with demonstrated ability to translate complex regulatory, scientific, or operational content for diverse audiences, including executive leadership, Health Authorities, and cross-functional partners.
  • Skilled at preparing and delivering compelling presentations, briefing documents, and strategic updates to cross-functional leadership teams, board-level stakeholders, and external regulatory agencies.
  • Adept at facilitating productive dialogue in high-stakes meetings, Health Authority interactions, and multi-party collaborations; balances clarity, diplomacy, and scientific precision

Salary Range:

The expected salary range for this position varies by location and will be communicated based on the country or region in which the selected candidate is hired. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by applicable local law. A discretionary annual bonus and long-term incentive award (e.g., equity) may be available based on individual and Company performance.

Salary Range

$242,000 - $313,500 USD

Benefits:

We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices. Benefits may include, but are not limited to:

  • Competitive health and wellness coverage (structure and premiums vary by country)
  • Paid time off, public holidays, and additional leave entitlements in accordance with local requirements
  • Flexible work arrangements / hybrid schedule

Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms. Specific benefit details applicable to your country or region will be provided during the offer process.

Equal Employment Opportunity:

Beeline Medicines is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, age, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

Reasonable Accommodation:

If you require a reasonable accommodation to participate in the application or interview process, please contact careers@beelinemedicines.com to request an accommodation. We are committed to providing equal access to all candidates.

Privacy

Upon submission of this form I understand that Beeline Medicines is based in the United States and personal data submitted in the form will be transferred and accessed in the U.S., Information about Beeline Medicines privacy practices can be found at Privacy Policy - Beeline Medicines

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

Select...
Select...
Select...
Select...

When you apply to a job on this site, the personal data contained in your application will be collected by Beeline Medicines Corporation (“Controller”), which is located at 200 Clarendon Street, Boston, MA 02116, United States and can be contacted by emailing Privacy@beelinemedicines.com. Controller’s data protection officer is James Finchen, who can be contacted at Privacy@beelinemedicines.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of Regulation (EU) 2016/679 (General Data Protection Regulation) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. Greenhouse is certified to the EU-U.S. Data Privacy Framework, which the European Commission has determined ensures an adequate level of protection – comparable to that of the EU – for personal data transferred from the EU.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have to right to data portability. In addition, you may lodge a complaint with an EU supervisory authority.

Select...

By acknowledging, I certify that the information I have provided in this application, resume, and any other materials submitted during the application process is true, complete, and accurate to the best of my knowledge. I understand that any false, misleading, incomplete, or omitted information may result in disqualification from further consideration for employment or, if discovered after hire, disciplinary action up to and including termination of employment.

I authorize the Company to contact my former employers, educational institutions, references, and other sources to the extent permitted by applicable law for purposes of verifying the accuracy of the information provided in this application (and/or in my resume) and gathering information regarding my work performance, academic performance/credentials and qualifications for the position(s) for which I am applying.

I understand that submission of this application does not guarantee employment and does not create an employment contract. If hired, I understand that my employment will be at will, meaning that either I or the Company may terminate the employment relationship at any time, with or without notice and with or without cause, subject to applicable law.

U.S. Standard Demographic Questions

We invite applicants to share their demographic background. If you choose to complete this survey, your responses may be used to identify areas of improvement in our hiring process.
Select...
Select...
Select...
Select...
Select...
Select...

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Beeline Medicines’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Select...
Select...
Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 07/31/2029

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.