Director of Regulatory Affairs

Location
San Francisco, CA, United States
Posted
Nov 12, 2020
Ref
22588356
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
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 (IND/CTA/NDA/MAA/IDE/PMA, as applicable) in compliance with all applicable regulatory requirements, and in alignment with corporate goals
  • 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
  • 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/BS degree required in a biological/physical sciences. Advanced degree preferred
  • 5+ years regulatory affairs experience in the biotech or pharmaceutical industry
  • Knowledgeable of US FDA and international pharmaceutical guidances, regulations, drug development process, and industry standard practices.
  • Experience in oncology required
  • Proven ability to think strategically
  • Proficient in written, oral, and interpersonal communications
  • Ability to manage complexity and uncertainty
  • Ability to work in a small company within a largely virtual environment; small biotech/pharma experience preferred
  • 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