Senior Manager/Associate Director, Regulatory Sciences

BridgeBio Pharma•San Francisco, CA

13d•Hybrid

About The Position

In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. Together we define white space, push boundaries, and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. At BridgeBio, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.

Requirements

PhD with 7+ years relevant experience, or BS/MS with 10+ years relevant experience.
Combination of experience in CMC development and regulatory authoring is preferred.
Familiarity with FDA, EMA, and ICH guidelines for INDs/NDAs/MAAs.
Thorough understanding of cGMP, quality and regulatory requirements for drug substance and drug product manufacturing.
Ability to interpret regulatory requirements and collaborate with development and/or commercial teams to create actionable plans to meet these requirements.
Working knowledge of analytical method development, validation, and global stability requirements.
Ability to develop strategies, make decisions, and advise technical teams in ambiguous regulatory landscapes.
Strong attention to detail and time management skills.
Excellent oral and written communication skills.
Excellent organizational skills and demonstrated ability to deliver on multiple projects simultaneously with tight timelines.
Ability to effectively interface with and/or manage highly skilled internal staff.
Ability to work independently as well as in a team.
Ability to build good working relationships.

Nice To Haves

Background in drug product or analytical development is a plus.

Responsibilities

Collaborate with small molecule CMC technical teams to design and implement drug substance and drug product control strategies to meet current and evolving regulatory requirements throughout a program’s life cycle.
Author and review technically complex drug substance and drug product sections of clinical trial applications and supplements (e.g., IND, IMPD, CTA), and marketing authorization applications and post-approval changes/variations (e.g., NDA, MAA, JNDA) in collaboration with subject matter experts and stakeholders.
Author responses to health authority queries and information requests related to Quality sections of clinical and marketing approval applications.
Prepare and maintain quality risk assessments, including but not limited to, identification and control of (potentially) mutagenic impurities in accordance with ICH M7, elemental impurities in accordance with ICH Q3D, and nitrosamines in accordance with global regulatory guidelines.
Advise development teams on the selection and justification of regulatory starting materials, establishment of specifications, and characterization of manufacturing processes.
Identify key regulatory issues with potential impact across multiple projects. Raise awareness with and appropriately influence affected teams.
Apply AI-enabled tools and digital technologies to improve the efficiency, quality, and consistency of regulatory submissions while adhering to company policies and data governance standards
Interface with International Regulatory Affairs, CMC Regulatory Affairs, Supply Chain Management, and CMC technical teams on global launch sequence, filing strategies, and regional filing requirements which may impact CMC manufacturing timelines, stability, and/or control strategies.

Benefits

Market-leading compensation
401(k) with employer match
Employee Stock Purchase Program (ESPP)
Pre-tax commuter benefits (transit and parking)
Referral bonus for hired candidates
Subsidized lunch and parking on in-office days
100% employer-paid medical, dental, and vision premiums for you and your dependents
Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)
Fertility & family-forming benefits
Expanded mental health support (therapy and coaching resources)
Flexible, “take-what-you-need” paid time off and company-paid holidays
Comprehensive paid medical and parental leave to care for yourself and your family
Career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching
Financial rewards, peer-to-peer recognition, and growth opportunities