Senior Director, Regulatory Strategy – Global Regulatory Lead

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 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; translat

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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 — $313,000 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