Senior Director, Regulatory Affairs

Location: Remote (Preference for Pacific Time Zone)
Role Type: Full‑Time | Senior Leadership

About the Role

We are seeking a Senior Director of Regulatory Affairs to lead global regulatory strategy and execution across an expanding portfolio of early‑ and mid‑stage development programs. This individual will serve as the organization's senior regulatory expert, partnering closely with cross‑functional teams and guiding programs from pre‑IND through clinical development. The role is fully remote with a preference for candidates who can work effectively across Pacific Time Zone hours to support global collaboration.

Key Responsibilities

Regulatory Strategy

• Develop and implement global regulatory strategies to support clinical development plans and long‑term program objectives.
• Anticipate regulatory requirements, assess risks, and advise on mitigation strategies across clinical, nonclinical, and CMC areas.
• Provide clear, strategic regulatory guidance to functional leaders and project teams.

Health Authority Leadership

• Lead FDA and ex‑US health authority engagements, including meeting requests, briefing packages, and response strategies.
• Oversee preparation and submission of regulatory filings such as pre‑IND, IND, CTA, amendments, meeting packages, and safety updates.
• Ensure high‑quality, timely submissions that meet global regulatory standards.

Cross‑Functional Partnership

• Collaborate closely with clinical development, CMC, nonclinical, program management, and quality teams to ensure alignment across development activities.
• Offer regulatory perspective on protocols, study reports, risk assessments, and manufacturing or quality changes.
• Support internal teams in interpreting regulatory guidelines and preparing for future development phases.

Operational Excellence

• Oversee regulatory operations and documentation processes, ensuring compliance with eCTD and global submission requirements.
• Develop and refine SOPs, templates, workflows, and operational systems to support scalable growth.
• Manage regulatory vendors, consultants, and CRO partners.

Team Leadership

• Build, lead, and mentor a high‑performing regulatory team as organizational needs expand.
• Establish a culture of clarity, efficiency, and proactive planning within the regulatory function.

Qualifications

Required

• 12+ years of regulatory affairs experience in biotech/pharma, including leadership of global regulatory strategies.
• Demonstrated success advancing programs through early development, including authorship or ownership of INDs and CTAs.
• Direct experience leading FDA meetings and managing global health authority interactions.
• Strong understanding of regulatory expectations across clinical, nonclinical, and CMC disciplines.
• Ability to thrive in a dynamic, fast‑paced environment with shifting priorities.
• Excellent communication and cross‑functional collaboration skills.
• Ability to work effectively within Pacific Time Zone work hours.

Preferred

• Experience with advanced modalities (e.g., RNA, oligonucleotides, biologics, gene therapy).
• Experience in early‑stage, high‑growth biotech settings.
• Demonstrated ability to build functions, systems, or processes from the ground up.