Director of Regulatory Affairs

Location
San Francisco, CA, United States
Posted
Oct 14, 2020
Ref
22588356
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Who You Are

Navire is looking for a talented and motivated regulatory affairs leader to develop and execute global regulatory strategies aimed at the most efficient regulatory pathway for Navire's drug and/or diagnostic development programs. This involves collaboration with cross-functional project teams in planning development strategies and leading global regulatory submissions for assigned projects.

Responsibilities
  • Serve as key regulatory team member with responsibility for regulatory strategies and submissions for assigned projects
  • Provide regulatory guidance and strategy for support of product development and registration strategies, including broad regulatory oversight for nonclinical/clinical development
  • Ensure high-quality and timely regulatory submissions (IDE/PMA as well as IND/CTA/NDA/MAA, as applicable) in compliance with all applicable regulatory requirements, and in alignment with corporate goals
  • Act as the primary liaison between Navire and regulatory authorities
  • Direct and assist internal staff and regulatory consultants, as required, to ensure compliance of Navire's drug development activities with all U.S. and international requirements
  • Support due diligence and partnering activities, as needed
  • 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
  • Perform all duties in keeping with the Company's core values, policies and all applicable regulations

Education, Experience & Skills Requirements
  • BA required in a scientific/medical field; advanced degree preferred
  • 5+ years progressive, regulatory affairs experience in the biotech of pharmaceutical industry
  • Experience in oncology, IND submissions, and running Phase 1 clinical trials required
  • Ability to work in a small company with a largely virtual environment; Startup experience preferred
  • Ability to manage complexity and uncertainty
  • Strong team interaction and communication skills
  • Embraces company core values: 1. put patients first; 2. think independently, 3. be radically transparent; 4. every minute counts; and 5. let science speak

What We Offer
  • Patient Days, where we are fortunate enough to learn more about the lives we are looking to impact and a real exchange of ideas as to how we can improve our efforts
  • A culture inspired by our values: put patients first; think independently, be radically transparent; every minute counts, and let the science speak
  • Learning and development training to help employees be the best version of themselves
  • Collaborative business environment
  • Excellent compensation package (Base, Performance Bonus, Stock, RSU programs)
  • Excellent benefits package
  • Flexible PTO
  • With office locations in San Francisco, Boston, New York, and Raleigh, there are ample cross-collaboration opportunities with other BridgeBio Pharma programs
  • A fast-paced, data-driven, work environment with world-class R&D minds and capabilities
  • Work with the most productive groups of R&D operators in the industry
  • Partnerships with leading institutions
  • A platform for meaningful scientific contributions to shine
  • Commitment to Diversity & Inclusion - with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead, and supported in their efforts to do so