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Full-Time

Manager/Sr. Manager

Regulatory Affairs

Updated on 9/4/2024

BridgeBio

BridgeBio

501-1,000 employees

Develops medicines for genetic diseases

Biotechnology
Healthcare

Compensation Overview

$130k - $190kAnnually

+ Performance Bonus + Equity + Health Benefits

Mid, Senior

Remote in USA

Category
Public Health
Biology & Biotech
Required Skills
PowerPoint/Keynote/Slides
Requirements
  • Advanced degree (M.S., Pharm.D., Ph.D.) or B.S. Degree in Biology, Immunology, or related field
  • Minimum of 2 years of relevant regulatory affairs experience with an advanced degree or 5 years with a Bachelor’s degree, with proven strategic involvement with small molecule drugs and/or biologics development is required
  • Ability to analyze and interpret scientific data and regulations to apply to a drug development program
  • Evidence of being a critical strategic thinker who is solution-oriented with the ability to think outside of the box
  • Excellent written and oral communication skills
  • Fluent with Microsoft Office (Word, Excel, PowerPoint) and Adobe Acrobat (PDF) rendering software
Responsibilities
  • Ensure effective timeline management for preparing and reviewing submissions and applications, including ODAs, BTD, CTAs, INDs, NDAs, BLAs, MAAs and all equivalent submissions globally within the established timelines
  • Maintain all regulatory applications to ensure compliance with regulations, including the preparation, review, and execution of pre- and post-marketing submission activities
  • Assist the regulatory team by leading and advising cross-functional teams on assigned projects with regulatory strategies to help optimize and expedite product development
  • Assist in the Initiation and maintenance of regulatory applications to ensure compliance with regulations, including the preparation, review, and execution of pre- and post-marketing submission deliverables
  • Assist in the management of communications with regulators (globally) as assigned, including submission of informal and formal correspondences, responses to Agency requests for information, and pre-meeting packages; participate in the preparation and conduct of Agency meetings
  • Develop, maintain, and communicate timelines for regulatory submissions to ensure timely delivery of regulatory documentation
  • Manage coordination with Reg Operations Team (publishers) for assigned submissions to Agencies to ensure proper direction, preparation, and quality Q.C. is performed, and all submissions are timely and in compliance with all Agency laws
  • Participate in the review of critical documents such as protocols, ICFs, IBs, CSRs, DSURs, etc., to ensure compliance with relevant regulations and guidance (e.g., ICH, FDA, EMA, etc.)
  • Conduct Regulatory Intelligence related to the assigned programs and disseminate relevant information to Sr. Management and cross-functional teams
  • Work with Regulatory Affairs leadership to review and approve promotional and non-promotional materials as required
  • Assist with all regulatory business development efforts as needed

BridgeBio Pharma develops medicines specifically for genetic diseases, focusing on conditions with well-understood genetic causes. The company operates using a decentralized subsidiary model, where each subsidiary concentrates on creating therapies for particular diseases while sharing central resources. This structure enhances efficiency and allows for the simultaneous advancement of multiple drug programs. BridgeBio utilizes advancements in genome sequencing and molecular biology to identify and develop effective treatments. Unlike many competitors, BridgeBio emphasizes independent thinking and transparency, enabling rapid, data-driven decision-making. The company's goal is to create significant therapeutic advancements by targeting diseases at their genetic source, ultimately bringing effective treatments to market more quickly.

Company Stage

IPO

Total Funding

$6.8B

Headquarters

Palo Alto, California

Founded

2014

Growth & Insights
Headcount

6 month growth

15%

1 year growth

53%

2 year growth

56%
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Simplify's Take

What believers are saying

  • Significant investments, such as the $46.84 million from Norges Bank and $200 million for the oncology spinout, indicate strong financial backing and growth potential.
  • The launch of BridgeBio Oncology Therapeutics with $200 million in funding highlights the company's commitment to advancing cancer treatments, particularly KRAS inhibitors.
  • Equity grants to new employees under the Amended and Restated 2019 Inducement Equity Plan demonstrate BridgeBio's commitment to attracting and retaining top talent.

What critics are saying

  • The competitive landscape in genetic disease therapies and oncology is intense, with numerous companies vying for market share.
  • The decentralized subsidiary model, while efficient, may lead to challenges in maintaining cohesive strategic direction and operational alignment.

What makes BridgeBio unique

  • BridgeBio's decentralized subsidiary model allows for focused and efficient drug development across multiple genetic diseases simultaneously, unlike traditional centralized biopharma companies.
  • The company's emphasis on genetic diseases with well-understood causes enables targeted and potentially more effective therapies, setting it apart from competitors with broader, less focused pipelines.
  • BridgeBio's robust pipeline of over 15 drug programs targeting 20 different genetic diseases showcases its diversified approach, reducing the traditional biopharma process timeline.