Head of Regulatory Affairs

Head of Regulatory Affairs at Barrington James Head of Regulatory Affairs at Barrington James in Poway, California Posted in about 22 hours ago.

Type:

full-time

Job Description:

Head of Regulatory Affairs - Biotech (Oncology / Metabolic) We are working with a an exciting biotech company awith multiple late-stage programs progressing toward their first NDA filing, this is a high-impact leadership opportunity to establish and scale the global regulatory function at a critical stage of growth. The Head of Regulatory Affairs will set and drive end-to-end regulatory strategy. This role will be central in shaping global regulatory pathways, leading key interactions with health authorities, and ensuring high-quality IND and NDA submissions across the US, EU, and other major global markets.

Key Responsibilities:

Lead preparation and execution of IND, NDA, and global submissions across FDA and EMA Serve as the primary interface with health authorities, including FDA meetings (Type B, pre-NDA, and other key engagements) Drive late-stage regulatory strategy and NDA readiness activities, including submission planning, coordination, and execution Oversee development, review, and submission of regulatory documentation Build, develop, and lead the regulatory affairs organization, including internal capability building and external partner oversight Strategic input to executive leadership on risks, timelines, and opportunities impacting development and commercialization

Qualifications:

Bachelors 9+ years of Regulatory Affairs experience Oncology and/or Metabolic disease Leadership experience in regulatory affairs within biotech or pharmaceutical environments Experience IND and NDA/BLA submissions Deep experience working with FDA, with additional exposure to EMA and other global regulatory authorities Strong background in late-stage development and global regulatory strategy Success leading health authority interactions and shaping regulatory outcomes