Senior Director, Regulatory Affairs CMC – Biologics

The posting, as Beeline Medicines wrote it

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 Do

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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