BridgeBio
Director/Sr. Director Regulatory Affairs
BridgeBio, San Francisco, California, United States, 94199
Director/Sr. Director Regulatory Affairs
Mavericks Wanted
When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement... read on.
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.
What You’ll Do The Director/Senior Director of Regulatory Affairs will lead global regulatory strategy and execution across all stages of drug development and registration. This role requires both high‑level strategic oversight and hands‑on involvement in regulatory submissions. The ideal candidate is a proactive leader with deep regulatory expertise and proven experience navigating complex global regulatory landscapes in a dynamic, fast‑moving pharmaceutical environment.
Responsibilities
Lead post‑marketing regulatory activities, including lifecycle management of approved products and all related amendments (e.g., labeling updates, safety variations, and manufacturing or formulation changes)
Develop and execute forward‑thinking global regulatory strategies to support late‑stage development, approval, product launch and lifecycle management
Lead interactions with health authorities, including preparation for regulatory meetings, managing agency correspondence, and coordinating timely responses to inquiries
Act as the lead regulatory affairs representative in the planning and conduct of international clinical trials, ensuring alignment with global regulatory requirements and ethical standards
Serve as the regulatory lead in senior leadership and cross‑functional forums, ensuring alignment on regulatory objectives, risks, and opportunities
Provide expert guidance to internal teams on regulatory pathways, requirements, and best practices across global markets (e.g., FDA, EMA)
Oversee the planning, preparation, and timely submission of high‑quality regulatory filings, including INDs, CTAs, NDAs, MAAs, and associated amendments or supplements
Collaborate with project managers to develop and maintain regulatory submission timelines, ensuring deliverables are completed on schedule and aligned with program priorities
Partner with external stakeholders and vendors to coordinate submissions and ensure compliance with regulatory requirements
Lead or contribute to the development and maintenance of regulatory SOPs and internal guidance documents
Support due diligence and partnering activities as needed
Where You’ll Work This is a hybrid role and requires in‑office collaboration 2‑3× per week in our San Francisco Office.
Who You Are
A Bachelor’s degree in a scientific field is required; an advanced degree (MD, Ph.D., PharmD, MS) is preferred
A minimum of 15 years of relevant experience in pharmaceutical/biotechnology regulatory affairs, including leadership of a Regulatory Affairs group
Strong attention to detail, with the ability to manage multiple projects under tight deadlines and work independently
Proven experience leading eCTD‑formatted submissions (e.g., INDs, NDAs/BLAs, MAAs, annual reports, amendments, and supplements) for drugs and/or biologics
Demonstrated success in leading responses to health authorities and other critical submissions while meeting agreed timelines
Special Skills / Knowledge
Excellent oral and written communication skills, along with strong time management abilities
Proven ability to work effectively with, and/or lead, cross‑functional teams (e.g., research, clinical, and CMC teams)
Skilled in developing regulatory plans and strategies while proactively identifying and mitigating risks
Capable of managing multiple tasks with strong attention to detail to support company objectives
Solid knowledge of ICH, GCP, GMP, and other relevant global regulatory guidelines
Proficient in computer applications such as MS Word, Excel, PowerPoint, and electronic document management systems
Rewarding Those Who Make the Mission Possible
Market leading compensation
401K with 100% employer match on first 3% & 50% on the next 2%
Employee stock purchase program
Referral program with $2,500 award for hired referrals
Comprehensive health care with 100% premiums covered – no cost to you and dependents
Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
Hybrid work model – employees have the autonomy in where and how they do their work
Unlimited flexible paid time off – take the time that you need
Paid parental leave – 4 months for birthing parents & 2 months for non‑birthing parents
Flex spending accounts & company‑provided group term life & disability
Subsidized lunch via Forkable on days worked from our office
Skill Development & Career Paths
People are part of our growth and success story – from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
We celebrate strong performance with financial rewards, peer‑to‑peer recognition, and growth opportunities
At BridgeBio, we strive to provide a market‑competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi‑state employer, and this salary range may not reflect positions based in other states.
$255,000 - $315,000 USD
#J-18808-Ljbffr
When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement... read on.
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.
What You’ll Do The Director/Senior Director of Regulatory Affairs will lead global regulatory strategy and execution across all stages of drug development and registration. This role requires both high‑level strategic oversight and hands‑on involvement in regulatory submissions. The ideal candidate is a proactive leader with deep regulatory expertise and proven experience navigating complex global regulatory landscapes in a dynamic, fast‑moving pharmaceutical environment.
Responsibilities
Lead post‑marketing regulatory activities, including lifecycle management of approved products and all related amendments (e.g., labeling updates, safety variations, and manufacturing or formulation changes)
Develop and execute forward‑thinking global regulatory strategies to support late‑stage development, approval, product launch and lifecycle management
Lead interactions with health authorities, including preparation for regulatory meetings, managing agency correspondence, and coordinating timely responses to inquiries
Act as the lead regulatory affairs representative in the planning and conduct of international clinical trials, ensuring alignment with global regulatory requirements and ethical standards
Serve as the regulatory lead in senior leadership and cross‑functional forums, ensuring alignment on regulatory objectives, risks, and opportunities
Provide expert guidance to internal teams on regulatory pathways, requirements, and best practices across global markets (e.g., FDA, EMA)
Oversee the planning, preparation, and timely submission of high‑quality regulatory filings, including INDs, CTAs, NDAs, MAAs, and associated amendments or supplements
Collaborate with project managers to develop and maintain regulatory submission timelines, ensuring deliverables are completed on schedule and aligned with program priorities
Partner with external stakeholders and vendors to coordinate submissions and ensure compliance with regulatory requirements
Lead or contribute to the development and maintenance of regulatory SOPs and internal guidance documents
Support due diligence and partnering activities as needed
Where You’ll Work This is a hybrid role and requires in‑office collaboration 2‑3× per week in our San Francisco Office.
Who You Are
A Bachelor’s degree in a scientific field is required; an advanced degree (MD, Ph.D., PharmD, MS) is preferred
A minimum of 15 years of relevant experience in pharmaceutical/biotechnology regulatory affairs, including leadership of a Regulatory Affairs group
Strong attention to detail, with the ability to manage multiple projects under tight deadlines and work independently
Proven experience leading eCTD‑formatted submissions (e.g., INDs, NDAs/BLAs, MAAs, annual reports, amendments, and supplements) for drugs and/or biologics
Demonstrated success in leading responses to health authorities and other critical submissions while meeting agreed timelines
Special Skills / Knowledge
Excellent oral and written communication skills, along with strong time management abilities
Proven ability to work effectively with, and/or lead, cross‑functional teams (e.g., research, clinical, and CMC teams)
Skilled in developing regulatory plans and strategies while proactively identifying and mitigating risks
Capable of managing multiple tasks with strong attention to detail to support company objectives
Solid knowledge of ICH, GCP, GMP, and other relevant global regulatory guidelines
Proficient in computer applications such as MS Word, Excel, PowerPoint, and electronic document management systems
Rewarding Those Who Make the Mission Possible
Market leading compensation
401K with 100% employer match on first 3% & 50% on the next 2%
Employee stock purchase program
Referral program with $2,500 award for hired referrals
Comprehensive health care with 100% premiums covered – no cost to you and dependents
Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
Hybrid work model – employees have the autonomy in where and how they do their work
Unlimited flexible paid time off – take the time that you need
Paid parental leave – 4 months for birthing parents & 2 months for non‑birthing parents
Flex spending accounts & company‑provided group term life & disability
Subsidized lunch via Forkable on days worked from our office
Skill Development & Career Paths
People are part of our growth and success story – from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
We celebrate strong performance with financial rewards, peer‑to‑peer recognition, and growth opportunities
At BridgeBio, we strive to provide a market‑competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi‑state employer, and this salary range may not reflect positions based in other states.
$255,000 - $315,000 USD
#J-18808-Ljbffr