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Vp, Regulatory Affairs

15+ years
$305,000 - $365,000 USD
10 Nov. 27, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

VP, Regulatory Affairs

Location: San Francisco, CA/Hybrid

About BridgeBio:
BridgeBio is a cutting-edge biopharmaceutical company focused on developing transformative medicines for genetic diseases and genetically driven cancers. Founded in 2015, the company boasts a robust portfolio of 20+ programs ranging from preclinical to late-stage development across dermatology, oncology, cardiology, neurology, pulmonology, and more, including two approved drugs.

With a commitment to scientific excellence and rapid execution, BridgeBio bridges the gap between academic breakthroughs and meaningful patient treatments. The company operates across the U.S. (San Francisco, Palo Alto, Raleigh) and internationally in Canada and Switzerland, with plans to expand in Europe.

Visit us: https://bridgebio.com


Role Overview:

As VP of Regulatory Affairs, you'll lead global regulatory strategies across BridgeBio's affiliate companies, ensuring timely advancement of assets. This pivotal role includes interfacing with regulatory agencies worldwide, managing risks, overseeing clinical trial compliance, and leading regulatory submissions.

Key Responsibilities:

  • Develop and execute global regulatory strategies for product development and approvals.
  • Oversee submissions to FDA, EMA, and global health authorities.
  • Collaborate with senior leadership on strategic regulatory plans.
  • Represent regulatory affairs in senior management discussions.
  • Lead a dynamic team, balancing strategic oversight and hands-on contributions.

Who You Are:

  • Experience: 15+ years in pharmaceutical/biotechnology regulatory affairs with leadership experience.
  • Education: Bachelor's in a scientific field (Advanced degree preferred: MD, PhD, PharmD, MS).
  • Skills:
    • Expertise in global regulatory requirements and drug development processes.
    • Strong project management and interpersonal skills.
    • Proven ability to influence, lead teams, and manage multiple priorities.

What We Offer:

  • A patient-first culture driven by core values: innovation, transparency, and rapid execution.
  • Opportunities for career advancement and cross-program collaboration.
  • Competitive compensation: Base salary ($305K–$365K), bonuses, equity, and health benefits.
  • Flexible PTO and professional development resources.
  • Partnerships with leading institutions and access to a decentralized decision-making model.

Diversity, Equity & Inclusion:
BridgeBio is committed to fostering a diverse and inclusive workplace.


Join Us:

Step into a collaborative, fast-paced environment where science meets innovation to create tomorrow's medicines today.