Director, Regulatory CMC

BridgeBio Pharma

2d•$245,000 - $285,000•Hybrid

About The Position

We are seeking a Director, Regulatory CMC to join our innovative team. This role is for individuals who thrive on achieving the impossible and are excited by the prospect of pushing boundaries in the biopharmaceutical industry. At BridgeBio, we pioneer a unique approach to drug development, focusing on rare diseases and unmet medical needs. We foster a culture of curiosity, experimentation, and collaboration, empowering our teams to reengineer the future of medicine. If you are a visionary leader who defies convention and is passionate about making a difference, we invite you to join us.

Requirements

Minimum of a Bachelor's degree in a relevant scientific discipline (e.g., Chemistry, Biology, Pharmacy).
Significant experience in regulatory affairs, with a strong focus on CMC.
Proven track record of successful regulatory submissions and interactions with health authorities.
In-depth knowledge of global CMC regulatory requirements and guidelines.
Excellent communication, interpersonal, and leadership skills.
Ability to thrive in a fast-paced, innovative environment.
Experience in the biopharmaceutical industry.

Nice To Haves

Advanced degree (Master's or Ph.D.) in a relevant scientific field.
Experience with rare disease drug development.
Familiarity with AI tools to enhance work processes.

Responsibilities

Lead and manage all aspects of Chemistry, Manufacturing, and Controls (CMC) regulatory activities for drug development programs.
Develop and implement regulatory strategies for CMC submissions, including INDs, NDAs, and other relevant filings.
Ensure compliance with global regulatory requirements and guidelines.
Liaise with regulatory agencies (e.g., FDA, EMA) on CMC-related matters.
Oversee the preparation and review of CMC sections of regulatory submissions.
Provide regulatory guidance and support to CMC development teams.
Stay abreast of evolving CMC regulatory landscape and advise the organization accordingly.

Benefits

Market-leading compensation
Annual performance bonus
Company equity
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
Flexible Spending Accounts (FSA)
Fertility & family-forming benefits
Expanded mental health support (therapy and coaching resources)
Hybrid work model with flexibility
Flexible, “take-what-you-need” paid time off and company-paid holidays
Comprehensive paid medical and parental leave
Opportunities for skill development and internal mobility
Career pathing through regular feedback
Continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching