Director, Global Regulatory Strategy

The company is a clinical‑stage biotechnology company advancing clinical development of novel therapeutic candidates for autoimmune and inflammatory diseases with significant unmet medical need. Our work is focused on understanding immune‑mediated disease and translating that science into carefully designed clinical programs, with patients and their challenges guiding our approach.

The company is building and advancing a growing portfolio of clinical programs informed by strong scientific expertise and disciplined execution. Across the organization, teams work closely together to progress development thoughtfully, with a shared emphasis on data quality, rigor, and integrity.

At the company, we operate as One the company. This means collaborating across functions, valuing diverse perspectives, and taking shared ownership of our work—from problem‑solving to execution. Joining the company means contributing to patient‑focused clinical development in a hands‑on environment where individual effort matters, collaboration is expected, and people are encouraged to grow while working toward a common goal.

What You’ll Do

We are seeking a highly motivated and experienced Director, Global Regulatory Strategy to join our dynamic team at the company, a growing biotech company. The ideal candidate will be collaborative, science-driven, and passionate about working on innovative investigational products.

The Director, Global Regulatory Strategy will be the strategic regulatory driver for one or more monoclonal antibody (mAb) and biologic-device combination product development programs. This role will be accountable for creating and executing innovative global regulatory strategies that support efficient clinical development and global commercialization.

As Director, Global Regulatory Strategy, you will develop and lead global health authority interactions — including End-of-Phase 2 (EOP2) FDA meetings, EMA Scientific Advice, and other critical agency engagements to align development plans and facilitate approvals. Additionally, you will oversee the preparation and submission of high-quality global regulatory submissions, including INDs, CTAs, and amendments, ensuring compliance with regional and global requirements.

Responsibilities

• Global Regulatory Strategy: Lead the development and execution of regulatory strategies for assigned programs, ensuring alignment with senior leadership, development goals, and worldwide regulatory requirements to drive product development.

• Health Authority Interactions: Lead the strategy, preparation, and execution of major global health authority interactions, including FDA End-of-Phase 2 meetings, EMA Scientific Advice, and other milestone regulatory discussions, and serve as the primary health authority contact for assigned programs.

• Global Submission Leadership: Own planning, coordination, and execution of global regulatory submissions, including initial clinical trial applications (INDs, CTAs), subsequent amendments or substantial modifications, and notifications, and lead early planning for marketing applications (BLA/MAA).

• Risk Management: Anticipate regulatory challenges, assess risks, and develop mitigation strategies to minimize impact to development timelines and approvals, escalating key risks to senior leadership with recommended options.

• Team Leadership: Lead and mentor members of the regulatory sub-team, fostering a culture of collaboration, accountability, and continuous learning. Represent Regulatory Affairs on program core teams, ensuring alignment across cross-functional departments.

• Competitive and Regulatory Landscape Analysis: Monitor and interpret evolving global regulatory policy, guidance, and precedent, translating insights into strategic recommendations for program teams and senior leadership.

• Documentation and Review: Perform regulatory review of clinical and nonclinical documents, including investigator’s brochures, study protocols, clinical study reports, labeling, and application summaries.

Required Qualifications

• Minimum of 10 years’ experience in the pharmaceutical/biotech industry, with a minimum of 8 years’ experience in drug/biologic regulatory affairs.

• Proven track record of leading global regulatory strategy for complex development programs from early- to late-stage development.

• Demonstrated experience leading and/or supporting major health authority interactions (e.g., FDA EoP2).

• Experience shaping the regulatory strategy and design of pivotal clinical studies.

• In-depth understanding of global regulatory requirements for biologics, including ICH guidelines, GCP, and region-specific regulatory frameworks.

• Strong verbal and written communication skills, with the ability to clearly articulate regulatory strategies and risks.

• Ability to thrive in a dynamic, fast-paced environment, and manage multiple priorities across different time zones and cultures.

• Leadership: Proven ability to lead and motivate teams toward achieving joint objectives and business goals.

• Proven ability to influence decision-making by cross-functional teams, senior leadership, and governance committees.

• Excellent organizational and program management skills that ensure timely completion of objectives by appropriate prioritization, scheduling and assignment of tasks.

Preferred Qualifications

• Experience with monoclonal antibodies & biologic-device combination products strongly preferred.

• Experience in rare disease drug development, innovative trial design, and expedited regulatory pathways is highly desired.

• Experience supporting regulatory inspections and Phase 3 readiness activities is preferred.

Education

• Bachelor’s degree in a scientific discipline (pharmacy, biology, chemistry, pharmacology) or related subject. Advanced degree or certification, preferred.

Expected Salary Range

$196,000 - $236,000 USD

Our current benefits offerings include

• Medical, Dental, and Vision Plans

• Life and Disability Insurance

• Health Savings Account (HSA) and Flexible Spending Account (FSA)

• Equity Compensation

• Performance‑Based Bonus Program

• 401(k) Plan with Company Match

• Paid Time Off and Company Holidays

• Paid Parental Leave