Location: Washington, DC. Work Schedule: Hybrid—minimum 3 days per week in office.
Responsibilities:
- Lead BridgeBio’s regulatory policy, agency engagement, and regulatory intelligence function; build and lead a team.
- Regulatory Policy: Monitor and shape evolving FDA/EMA (and other agency) policy; track rules/guidance/initiatives; engage coalitions/trade associations; develop company positions to inform strategy and stakeholder engagement.
- Regulatory Engagement: Proactively manage relationships with FDA, EMA, and other global health authorities to advance programs, streamline regulatory pathways, and establish credibility.
- Regulatory Intelligence & Strategic Translation: Gather/synthesize/translate intelligence into actionable strategy; inform NDA/BLA strategy, label negotiations, regulatory risk assessments, and portfolio planning.
- Cross-functional leadership: Collaborate with clinical, regulatory, medical affairs, legal, and commercial teams to incorporate policy and intelligence into strategy.
- Team leadership: Recruit/retain talent; set priorities; coach/mentor; foster excellence, accountability, and continuous learning.