Full-Time

Manager/Sr. Manager

Regulatory Affairs

Posted on 8/8/2024

BridgeBio

BridgeBio

501-1,000 employees

Develops medicines for genetic diseases

Biotechnology

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 uses a decentralized subsidiary model, allowing each subsidiary to concentrate on specific therapies while sharing central resources. This structure enhances efficiency and enables the advancement of multiple drug programs at once. BridgeBio utilizes advancements in genome sequencing and molecular biology to identify and develop effective treatments. Their goal is to create significant therapeutic improvements by targeting diseases at their genetic source. With over 15 drug programs aimed at 20 different genetic diseases, BridgeBio aims to bring treatments to market more quickly than traditional biopharma processes. The company promotes a culture of independent thinking and transparency, which supports rapid, data-driven decision-making.

Company Stage

IPO

Total Funding

$704.4M

Headquarters

Palo Alto, California

Founded

2014

Growth & Insights
Headcount

6 month growth

3%

1 year growth

2%

2 year growth

-2%
Simplify Jobs

Simplify's Take

What believers are saying

  • Significant investment by Norges Bank shows strong investor confidence in BridgeBio.
  • Partnership with PANTHERx Rare enhances market penetration for rare disease therapies.
  • KRAS inhibitors development positions BridgeBio in a promising cancer treatment market.

What critics are saying

  • Alnylam's RNAi therapy poses competitive pressure on BridgeBio's Attruby.
  • Decentralized model may challenge cohesive strategic direction across programs.
  • Increased competition in KRAS inhibitors could impact BridgeBio's market share.

What makes BridgeBio unique

  • BridgeBio employs a decentralized subsidiary model for efficient drug development.
  • Focus on genetic diseases allows targeting conditions with well-understood genetic causes.
  • Partnerships with specialty pharmacies enhance patient access to rare disease therapies.

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Benefits

Health Insurance

Performance Bonus

Company Equity

Unlimited Paid Time Off

INACTIVE