Senior Manager, Regulatory Publishing and Operations

Full-TimeBridgeBioAny Office LocationRegulatory Affairs

Apply Now

BridgeBio finds, develops, and delivers breakthrough medicines for genetic diseases. The company bridges remarkable advancements in genetic science with the entrepreneurial engine required to rapidly create lifesaving medicines for patients with unmet needs. Founded in 2015 by a team of industry veterans, the company has built a portfolio of 20 transformative drugs ranging from pre-clinical to late-stage development in multiple therapeutic areas including genetic dermatology, oncology, cardiology, neurology, endocrinology, renal disease, and ophthalmology. The company’s focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have offices in the US (San Francisco, Palo Alto, Boston, New York, Raleigh), and EMEA (Zug, Switzerland) with small satellites in other parts of the country. 

To learn more, visit us at https://bridgebio.com

Who You Are:

Reporting to the Head of Regulatory Publishing and Operations at BridgeBio Services, the Senior Manager will support day-to-day regulatory operations activities of assigned projects.  These include preparing and compiling submissions for regulatory agencies, assigned clinical studies, managing regulatory submission processes and timelines, and regulatory tracking tools, archives, and infrastructure, as assigned.
Responsibilities:
  • Lead the U.S. FDA and select EU submission projects in conjunction with Regulatory Affairs teams at affiliates
  • Manage submission preparation, transmission, and archival, ensuring adherence with internal processes and regional standards
  • Manage and perform submission publishing to meet deadlines and high-quality standards (e.g., SPL, eCTD)
  • Advice on regional and technical requirements for submission documents
  • Provide subject matter expertise for the formatting and management of submission documents
  • Provide the Authoring Template and the "Reference Manager Software User" training
  • Contribute to process improvement initiatives
  • Assist with other regulatory activities and special projects, as needed

  • Serve as an administrator to Electronic Document Management System (Veeva RIM):
  • Manage users and application of Dynamic Access Control
  • Manage loader and bulk actions
  • Manage Submissions Content Planning
  • Manage Submissions Archive
  • Participate in Managed Service Check-in/Impact Assessment of new releases
Education, Experience & Skills Requirements:
  • Bachelor's degree in life science or relevant discipline required
  • 3+ years of in-depth regulatory operations experience in pharmaceutical and/or biotech product development
  • 4+ years pharmaceutical or biotech industry experience
  • Recent experience (within 2 years) successfully managing the creation and submission of regulatory documents that have been accepted on technical grounds at first pass
  • Experience with regulatory submissions and formatting and tools/systems, including documents required by INDs, NDAs, CTAs, and MAAs, supplements, and briefing documents
  • Electronic Document Management Systems (Veeva RIM)
  • Endnote
  • Knowledge and utilization of submission requirements and guidance
  • Working knowledge of ICH, FDA, and EMA submission guidelines plus 21 CFR Part 312 and 314
  • Strong experience with 21 CFR Part 11, 210 and 211
  • Detail-oriented, organized, and committed to quality and consistency
  • Deadline driven, capable of managing competing for high-priority assignments
  • Excellent written and verbal communication skills
  • Excellent team-interaction skills and ability to work successfully in cross-functional teams
  • Ability to work in a dynamic environment with a high degree of flexibility
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
We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.
careers

Senior Manager, Regulatory Publishing and Operations

Full-TimeBridgeBioAny Office LocationRegulatory Affairs

Apply Now