BridgeBio

Senior Director, Regulatory Affairs

BridgeBio

full-time

Posted on:

Location Type: Hybrid

Location: San Francisco • California • United States

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Salary

💰 $270,000 - $320,000 per year

Job Level

Senior

About the role

  • Provide leadership in creating and executing proactive regulatory strategies for product development, approval, and registration
  • Apply knowledge of global quality/regulatory standards and guidelines to ensure requirements are met across programs
  • Partner with internal senior leadership to align closely on cross-functional global regulatory plans and the company's short and long-term strategic objectives
  • Take complete ownership of relevant regulatory submission deliverables
  • Represent regulatory in senior management discussions and present strategies, recommendations, and risks accordingly
  • Lead the specific Affiliate regulatory strategy team by managing, mentoring, and teaching capabilities
  • Work at both high-level strategic and hands-on in leading an agile team
  • Serve as key regulatory team member with responsibility for regulatory strategies and submissions lead asset
  • Provide regulatory guidance and strategy for support of product development and registration strategies
  • Ensure high-quality and timely regulatory submissions (IND/CTA/NDA/MAA/IDE/PMA, as applicable) in compliance with all applicable regulatory requirements, and in alignment with corporate goals
  • Provide leadership and oversight of the preparation of all critical global regulatory submissions (from pre-IND to post-marketing) to the FDA, EMA, and other international health authorities
  • Act as the primary liaison with regulatory authorities
  • Direct and assist internal staff and regulatory consultants, as required, to ensure compliance of drug development activities with all U.S. and international requirements
  • Analyze and communicate current regulatory guidance and regulations, as well as industry and regulatory agency best practices and trends, to keep company informed on any relevant changes in the regulatory landscape
  • Support due diligence and partnering activities, as needed
  • Perform all duties in keeping with the Company’s core values, policies and all applicable regulations

Requirements

  • Bachelor's degree in the scientific field is required; an advanced degree (MD, Ph.D., PharmD, MS) preferred
  • A minimum of 15 years of relevant pharmaceutical/biotechnology regulatory affairs experience in the pharmaceutical industry, including expertise leading a Regulatory Affairs group
  • Well-versed in the drug development process and regulatory requirements, as well as a good understanding of the underlying science
  • Strong attention to detail
  • Excellent written and verbal communication skills
  • Excellent project management skills, with the ability to manage multiple projects and prioritize appropriately
  • Ability to rapidly understand & analyze complex problems/situations
  • Ability to lead teams under tight timelines and be willing to contribute significantly to day-to-day operations as needed
  • Comfort in a team environment
  • Strong interpersonal skills and the ability to effectively work with others
  • Ability to influence without authority, lead change
  • Ability to solicit information, persuade others, and shape outcomes
  • Experience working with all levels of management and consulting with key business stakeholders (internal and external)
  • Travel to key meetings and Health Authority interactions as needed
Benefits
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Applicant Tracking System Keywords

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Hard Skills & Tools
regulatory strategiesregulatory submissionsINDCTANDAMAAIDEPMAdrug development processregulatory requirements
Soft Skills
leadershipattention to detailwritten communicationverbal communicationproject managementproblem analysisteam leadershipinterpersonal skillsinfluence without authoritypersuasion
Certifications
Bachelor's degreeMDPh.D.PharmDMS