Senior Director Regulatory Affairs
EPM Scientific, California, MO, United States
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.
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.