Senior Director, Regulatory Affairs CMC – Biologics

Beeline Medicines; Cambridge (MA); Hybride; USD 242 000 - 314 000; Plein temps

Résumé du poste

Beeline Medicines in Cambridge, MA seeks a Senior Director of Regulatory Affairs CMC – Biologics to lead global biologics CMC strategy from IND/CTA to BLA and post‑approval lifecycle.

You will partner with Process Development, Analytical Sciences, Quality, and external CMOs to oversee submissions, health authority interactions, and regulatory strategy, shaping infrastructure for antibodies and large molecules in a fast‑paced biotech setting.

Qualifications

• 12+ years of CMC regulatory affairs experience in pharma/biotech.
• Experience authoring and overseeing biologics CMC sections of submissions (INDs/CTAs, BLAs, MAAs).
• Strong ability to lead Health Authority meetings (FDA/EMA) and regulatory strategy across lifecycle stages.

Responsabilités

• Develop and lead CMC regulatory strategy for all biologics assets from IND/CTA through BLA and post‑approval.
• Prepare biologics CMC sections of global regulatory submissions with scientific quality and defensibility.
• Lead Health Authority interactions including FDA/EMA meetings and responses to inquiries.
• Provide regulatory interpretation of ICH Q-series guidelines and guide development teams on process characterization and control strategy acceptability.
• Oversee post‑approval CMC change management and manufacturing transfers.
• Ensure submission readiness across cross‑functional teams and manage timelines.

Connaissances

CMC regulatory strategy

FDA/EMA interactions

Cross-functional leadership

ICH guidelines

Biologics expertise

Regulatory submissions

Formation

PhD/MS/PharmD in relevant biologics field

Description du poste

Senior Director, Regulatory Affairs CMC – Biologics

Cambridge, 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 – Biologics provides senior-level scientific and strategic regulatory leadership for all Chemistry, Manufacturing, and Controls (CMC) activities related to the company's biologics assets within the immunology and inflammation (I&I) portfolio, including monoclonal antibodies and other large molecule therapeutic modalities. This role is responsible for developing and executing biologics CMC regulatory strategies from early clinical development through BLA filing and post‑approval lifecycle management, serving as the company's foremost authority on biologics CMC regulatory science. The Senior Director collaborates closely with Process Development, Analytical Sciences, Quality, and external biologics CMOs to ensure that programs are developed, characterized, and submitted in alignment with FDA, EMA, and global Health Authority expectations for biological products. As a senior leader within the Regulatory Affairs organization, this individual also contributes to cross‑functional regulatory strategy and plays a foundational role in shaping the company's biologics CMC regulatory 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 biologics assets in the I&I portfolio, from IND/CTA through BLA and MAA filing, including post‑approval lifecycle management and labeling strategy for drug substance and drug product.
• Author, review, and oversee the preparation of biologics CMC sections of global regulatory submissions in ICH CTD format, including INDs/CTAs, BLAs, MAAs, supplements, and post‑approval variations, with accountability for scientific quality, completeness, and regulatory defensibility.
• Serve as the company's primary regulatory authority and strategic partner for biologics Process Development, Upstream and Downstream Manufacturing Sciences, Analytical Development, Formulation, and Quality functions on all CMC regulatory matters.
• Lead Health Authority interactions related to biologics CMC topics, including FDA Type B and Type C meetings (including BPD 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 and EMA biologics CMC guidance documents and ICH Q-series guidelines applicable to large molecules, including ICH Q8, Q9, Q10, Q11, Q12, and Q13, and advise development teams on process characterization, comparability, and control strategy regulatory acceptability.
• Lead post‑approval CMC change management strategy for biologics programs, including PACMP development, Prior Approval Supplements (PAS), CBE filings, and EU/global variation submissions related to manufacturing process changes, site changes, and analytical method updates.
• Oversee regulatory aspects of biologics technology transfer activities, including biosimilar comparability assessments, new CMO site qualification, and regulatory filing strategies for site‑to‑site manufacturing transfers.
• Provide regulatory guidance on biologics‑specific CMC considerations, including cell line development, cell banking, upstream and downstream process validation, biophysical and functional characterization, and extended characterization strategies.
• Contribute to regulatory due diligence evaluations of biologics licensing candidates or acquisition targets, assessing CMC regulatory risk, comparability study adequacy, and submission readiness.
• Tracks CMC regulatory deliverables and submission timelines across all biologics 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 biochemistry, molecular biology, pharmaceutical sciences, immunology, or a related biologics‑relevant discipline strongly preferred or equivalent years of experience.
• Minimum of 12+ years of CMC regulatory affairs experience in the pharmaceutical or biotech industry
• Deep and comprehensive expertise in biologics CMC regulatory strategy, including cell line development, upstream and downstream process development and validation, biophysical characterization, analytical method validation, and drug product formulation and fill‑finish for parenteral biologics.
• Extensive experience authoring and overseeing biologics CMC sections of global regulatory submissions, including INDs/CTAs, BLAs, MAAs, and post‑approval supplements and variations in ICH CTD/eCTD format.
• Demonstrated track record of leading FDA and EMA biologics CMC Health Authority meetings, including BPD (Biologics Product Development) meetings, pre‑BLA meetings, and strategic management of CMC deficiency letter responses
• Comprehensive knowledge of ICH Q8/Q9/Q10/Q11/Q12/Q13 guidelines, FDA biologics CMC guidance (including CDER and CBER guidance for therapeutic biologics), and EMA quality guidance applicable to monoclonal antibodies and other biological entities.
• Proven experience managing biologics‑specific CMC regulatory challenges, including comparability study strategy, reference standard lifecycle management, specification negotiation, and extended characterization regulatory justification.
• 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.
• Strong active listening skills and the ability to synthesize input from diverse perspectives into clear, actionable communications that build alignment and drive regulatory decision‑making.

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

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

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.

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 [e-mail] to request an accommodation. We are committed to providing equal access to all candidates.