Senior Director, Regulatory Strategy – Global Regulatory Lead

About this role

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 Strategy – Global Regulatory Lead is responsible for developing and leading the integrated global regulatory strategies for assigned programs in the immunology and inflammation (I&I) therapeutic area, with a particular focus autoimmune indications. This role serves as the primary regulatory strategist and Health Authority relationship lead for assigned programs, guiding development teams in the design of regulatory-sound development plans, optimal filing strategies, and Health Authority engagement. The Senior 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 leadership team, this individual also contributes to the development of the company's regulatory infrastructure, capabilities, and organizational best practices for program oversight.

Work Arrangement & Location:

Remote - This position is designated as remote; the incumbent will be expected to travel to Beeline Medicines’ offices on a periodic basis to support in-person collaboration, team engagement, and business operations. The frequency and scheduling of such visits will be determined at the company's discretion based on business need.

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, 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 12+ years of regulatory affairs experience in the pharmaceutical or biotech industry preferred, with at least 5–7 years of direct responsibility for global regulatory strategy leadership on clinical development programs

• 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…