Associate Director / Director of Regulatory Affairs

Location
San Francisco, CA
Salary
Competitive salary and benefits package
Posted
Dec 21, 2018
Ref
CCETDRA1
Required Education
Doctorate/PHD/MD
Position Type
Full time

Join a nimble, focused, thriving biotech as they enter Phase III trials for their first-in-class treatment for rare and devastating cardiovascular and neurological disorders.

  • Take responsibility for 2 global Phase 3 registration programs
  • Join a veteran team responsible for > 30 molecules through IND applications and > 10 approved drugs
  • Get involved in over 15 programs underway at related companies

About the company

Our client is a clinical-stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin, or TTR, amyloidosis, or ATTR. They seek to treat this well-defined family of diseases at their collective source by stabilizing TTR. Their product candidate, AG10, is an orally-administered small molecule designed to potently stabilize TTR, a potentially best-in-class treatment aiming to halt the progression of ATTR diseases.

About the role

Having just successfully completed their Phase 2 trials, they are preparing to enter Phase 3 trials and needs an exceptional Regulatory Affairs professional for this next, critical stage of their mission.

This role reports to the VP of Regulatory Affairs and Quality.

This role might suit you if you:

  •   Are capable of taking responsibility for 2, Phase 3 registration programs
  •   Thrive in an entrepreneurial environment
  •   Can operate as both a high-performing individual contributor and a great team-player
  •   Want to escape bureaucracy to work in a streamlined, efficient, high-performing team
  •   Want an easy commute via public transport (their office is located a short walk from the muni and BART lines) in the Financial District
  •  Want to contribute to REAL filings and Regulatory packages
  •  Can hit the ground running, bringing your experience and energy to make a real impact
  •  Want to interact on a professional and personal basis with the Regulatory Affairs teams at other BridgeBio companies, who regularly get together to socialize and to strategize around current regulatory challenges and approaches. This offers a unique opportunity to get involved in a range of programs across the family of companies, for career-development and for future career opportunities

Desirable experience

  • Small and / or large-molecule Regulatory Affairs experience
  • Cardiovascular / neurological products
  • Rare / orphan diseases
  • RAC / RAPS certification
  •  IND / CTA / NDA / MMA filing preparation, submission and approval
  • Expert knowledge of GXP / ICH requirements and Guidance