Director, Regulatory Strategy – Global Regulatory Lead

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 Director, Regulatory Strategy – Global Regulatory Lead is responsible for developing and leading the integrated global regulatory strategies for the company's early-stage and pipeline programs in the immunology and inflammation (I&I) therapeutic area, with a particular focus on lupus and adjacent autoimmune indications. This role serves as the primary regulatory strategist and Health Authority relationship lead for pre-IND through Phase II clinical programs, guiding development teams in the design of regulatory-sound development plans, optimal filing strategies, and early Health Authority engagement. The Director provides a global perspective across FDA, EMA, and other major regulatory jurisdictions, ensuring that regulatory strategy is proactively integrated into all aspects of early clinical and translational development. As a key member of the Regulatory Affairs team, this individual also contributes to the development of the company's regulatory infrastructure, capabilities, and organizational best practices for pipeline program oversight.

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 integrated global regulatory strategies for assigned pipeline programs in the I&I portfolio, encompassing pre-IND planning, IND/CTA submission strategy, Phase I/II/III development planning, and regulatory pathway optimization across major global jurisdictions including FDA, EMA, PMDA, and others.
• Serve as the primary regulatory strategist for assigned program teams, providing expert guidance on development plan design, regulatory risk identification, filing sequencing, and Health Authority engagement strategy.
• Lead the preparation and execution of regulatory meetings, including management of timelines, briefing document development, strategic meeting preparation, and agency interaction management; translate Health Authority feedback into actionable development recommendations.
• Develop and maintain integrated regulatory development plans (iRDPs) and regulatory timelines for all assigned programs, ensuring alignment with clinical, CMC, and non-clinical development activities and overall program milestones.
• Lead IND and CTA, NDA and BLA submissions, regulatory planning and submission of pediatric development plans.
• Provide strategic input to clinical protocols, non-clinical study designs, and early CMC development activities to ensure regulatory acceptability and alignment with global development strategy.
• Monitor and interpret evolving FDA and global regulatory guidance, precedent regulatory decisions, and competitive landscape intelligence relevant to I&I development programs, and proactively integrate insights into pipeline regulatory strategy.
• Evaluate and leverage expedited regulatory pathway opportunities for pipeline programs, including Breakthrough Therapy Designation (BTD), Fast Track Designation, PRIME designation (EMA), and Orphan Drug Designation where applicable.
• Partner with Regulatory Affairs CMC, Clinical Development, Non-Clinical Sciences, Bioanalytics, and Translational Sciences teams to ensure that cross-functional development activities are regulatory-strategy aligned from the earliest stages of development.
• Contribute to regulatory due diligence activities for pipeline asset evaluations, in-licensing candidates, and business development targets, assessing regulatory risk profiles, development pathway viability, and filing readiness.
• Maintain appropriate trackers of regulatory activities.
• Concise, clear and frequent communication with cross functional team. This position requires maturity, finesse and leadership to lead the cross-functional team, and high level of strategic acumen and finesse to define and lead regulatory interactions.
• Assess resource needs to support the assigned programs and with manager, participate in the development of the budget for assigned programs
• Perform other duties and responsibilities as assigned.

Qualifications:

• Education: Advanced degree (PhD, PharmD, or master's level) in a relevant life sciences discipline required.
• Minimum of 10+ years of regulatory affairs experience in the pharmaceutical or biotech industry, with at least 5 years of direct responsibility for global regulatory strategy leadership on clinical development programs preferred.
• Deep expertise in global regulatory strategy development for biologics and/or small molecule therapeutics, with demonstrated experience developing regulatory plans across FDA, EMA, and additional global jurisdictions from pre-IND through post approval.
• Extensive experience preparing and leading Health Authority interactions, including FDA pre-IND, Type B, and Type C meetings and EMA Scientific Advice meetings, with a strong track record of productive agency relationships and strategic translation of feedback.
• Thorough knowledge of FDA regulations (21 CFR Parts 312 and 314/601), EMA regulatory frameworks, ICH E8(R1), ICH E9(R1), and applicable guidance documents relevant to early clinical development in I&I or autoimmune disease indications.
• Prior experience in immunology, inflammation, autoimmune disease, or a related therapeutic area is strongly preferred; knowledge of lupus regulatory landscape and precedent regulatory decisions is a meaningful advantage.
• Strong strategic thinking skills, intellectual curiosity, and the ability to synthesize complex scientific and regulatory information into clear, actionable regulatory development recommendations.
• Demonstrated ability to operate independently, driving execution of regulato