Manager, Regulatory Affairs

Location
Brisbane, CA, United States
Posted
Aug 27, 2020
Ref
1086436773
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Who You Are

Reporting to a Director of Regulatory Affairs, the Manager of Regulatory Affairs will support the day-to-day regulatory activities of assigned projects. These assigned projects include support of preparation and compilation of submissions for regulatory agencies, tasked clinical studies, management of regulatory submission processes and timelines, regulatory tracking tools, archives, and infrastructure, as assigned.

Responsibilities
  • Provide ownership of study-level regulatory activities, including clinical trial application (CTA) and IND submissions, review and approval of investigator document packages and associated FDA submissions, and manage other regulatory aspects of the study as necessary
  • Provide regulatory guidance internally on study-level decision-making
  • Keep the study team informed of regulatory activities in the context of study team management meetings
  • Manage and track queries and commitments with regulatory agencies, collaborate with subject matter experts to provide written responses to queries, provide periodic status updates regarding unfulfilled conditions/commitments
  • Collaborate with the Project Team representatives in the planning of regulatory documents, including responses to Health Authority queries
  • Support processes by which regulatory submissions are reviewed, finalized, and signed-off
  • Manage the track record of regulatory/ethics submissions and approvals across all studies
  • Manage document archive processes
  • Support global regulatory submissions and strategic planning as applicable

Education, Experience & Skills Requirements
  • BA/BS degree in the biological or physical sciences preferred
  • Relevant pharmaceutical industry experience, including experience in regulatory affairs
  • Minimum 3 years of industry experience is generally required
  • Knowledgeable of US FDA and international pharmaceutical guidances, regulations, drug development process, and industry-standard practices
  • Proficient in written, oral, and interpersonal communications in English
  • Ability to work in close collaboration with colleagues in the regulatory department and throughout the development organization
  • Great attention to detail; ability to organize, prioritize, and delegate assigned projects
  • Experience interacting with CROs in the management of US eCTD IND submissions and ex-US CTAs towards clinical trial activations preferred
  • Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable

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