Director, Regulatory Affairs – Strategy

This is a fully remote position, open to applicants in Washington.

📋 Description

• Lead the global regulatory strategy for both development programs, encompassing target product profile, labeling, filing sequence, and expedited-pathway strategy.

• Convert regulatory strategy into scheduled plans that align with clinical, CMC, and program timelines.

• Oversee the regulatory critical path and identify risks while providing recommended solutions.

• Manage US marketing application readiness through submission-level authoring, sign-off, and comprehensive review-period management.

• Organize post-approval lifecycle management, covering commitments, supplements, and labeling modifications.

• Direct health authority strategy and execution during interactions with FDA and EMA, which includes preparing briefing packages, formulating question strategies, and conducting rehearsals.

• Anticipate regulatory risks, inquiries, and objections, developing proactive, evidence-based, and contingency strategies.

• Spearhead regulatory efforts to transition the early-phase program into late-phase development, achieving consensus on a registration-enabling design.

• Act as the primary point of contact for the company with FDA and manage international interactions through regional consultants and partners.

• Oversee consultants and vendors regarding scope, quality, and timelines.

• Incorporate regulatory considerations into clinical development, translational science, biostatistics, pharmacovigilance, regulatory operations, medical affairs, and CMC planning.

• Represent Regulatory Affairs on program teams and governance forums, reviewing regulatory content.

• Interpret regulatory requirements, intelligence, and health authority feedback into actionable recommendations.

• Establish submission standards, health authority processes, and a regulatory intelligence framework.

• Ensure compliance with ICH guidelines and internal SOPs.

• Function within a streamlined, cross-functional team with no direct reports upon hiring.

⛳️ Requirements

• An advanced degree in a life science discipline (PharmD, PhD, MD, MS) is preferred.

• At least 8 years of experience in biopharmaceutical regulatory affairs, including over 5 years in global regulatory strategy.

• Candidates with a higher level of education may be considered with less experience.

• Proven ownership of at least one US marketing application (NDA or BLA) or a significant US/EU submission, from readiness to submission and ideally approval.

• Direct experience leading FDA meetings as the regulatory lead, including briefing authorship and a speaking role.

• Experience in advancing a program from early to late-phase development, including reaching an agreement with a health authority on a registration-enabling design.

• Familiarity with ex-US requirements (EU CTR/CTIS, MAA, Scientific Advice) and knowledge of at least one other major region.

• Exceptional scientific writing and verbal communication skills, along with sound judgment under uncertain conditions.

• Competence in utilizing AI-enabled tools and innovative technologies for regulatory strategy, intelligence, authoring, data analysis, and operational efficiency while ensuring scientific rigor and compliance.

• Ability to establish, defend, and adjust regulatory strategies where precedents are limited, evolving, or subject to interpretation.

• Capacity to influence cross-functional teams, foster stakeholder alignment, and drive decisions without direct authority.

• Experience in balancing regulatory, scientific, operational, and benefit-risk considerations.

• Background in oncology and/or neurology, neurodegenerative, or rare disease development is preferred.

• Experience with expedited programs: Fast Track, Breakthrough Therapy, orphan drug designation, accelerated approval, or PRIME is favored.

• Preferred experience in companion diagnostics or drug-device co-development.

• Sufficient regulatory CMC literacy to collaborate effectively with a dedicated CMC regulatory counterpart.

• Experience in a lean biotechnology setting where strategic leadership, independent decision-making, and hands-on execution are essential.

🏝️ Benefits

• Approximately 10–15% travel required.

• Flexibility for West Coast time zone.

• Significant autonomy and direct access to executive leadership.

• Opportunity to influence regulatory strategy throughout the organization.

• Potential for team expansion over time.