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.