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 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.

Salary Range:

The expected salary range for this position varies by location and will be communicated based on the country or region in which the selected candidate is hired. Actual pay will 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

$211,500-$258,500 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.