Director, Regulatory Strategy – Global Regulatory Lead

Beeline Medicines • Boston, MA

1d • Hybrid

About The Position

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.

Requirements

• 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.
• 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 regulatory plans with agility and efficiency, while exercising sound judgment in stakeholder engagement, including proactively keeping leadership appropriately informed and involving senior management at key decision points.
• Able to manage multiple concurrent priorities with focus, efficiency, and sound judgment, balancing competing timelines and development milestones in a matrix biotech organization, with an appreciation for the visibility and criticality of programs in a small-company environment.
• Exceptional written and verbal communication skills with demonstrated ability to translate complex regulatory, scientific, or operational content for diverse audiences, including executive leadership, Health Authorities, and cross-functional partners.
• Demonstrated ability to communicate operational information into clear, actionable insights, providing decisive direction to teams and driving efficient, aligned execution across functions.
• Skilled at preparing and delivering compelling presentations, briefing documents, and strategic updates to cross-functional leadership teams, board-level stakeholders, and external regulatory agencies.

Nice To Haves

• 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.

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.
• 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.

Benefits

• Medical, Dental & Vision insurance (employee premiums 100% covered by company)
• 20 accrued days combined time off (PTO/Sick), 12 company holidays, & winter recharge
• Flexible work arrangements / hybrid schedule
• Health Savings Account (HSA)
• A discretionary annual bonus and long-term incentive award (e.g., equity) may be available based on individual and Company performance.

What This Job Offers

• Job Type: Full-time
• Career Level: Director