Executive Director, Regulatory CMC
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. At BridgeBio, we value curiosity and experimentation-including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.
What You'll Do
The Executive Director, Regulatory CMC provides strategic and operational leadership for global CMC regulatory activities across development and (as applicable) commercial products. This role partners closely with CMC, Quality, Technical Operations, Clinical, and Regulatory Affairs leadership to define regulatory CMC strategy, ensure high-quality submissions, and enable product development, licensure, and lifecycle management.
Responsibilities
CMC Regulatory Strategy & Leadership
• Define and execute global CMC regulatory strategies for investigational and marketing applications (e.g., IND/CTA/IMPD/MAA/NDA) and lifecycle changes.
• Serve as the primary CMC regulatory lead for one or more programs and/or as functional head for Regulatory CMC.
• Provide leadership, coaching, and development for Regulatory CMC staff and contractors; build scalable processes as the portfolio grows.
Submissions & Health Authority Interactions
• Lead preparation, review, and approval of CMC sections for regulatory submissions (Module 3, quality overall summaries, responses to information requests).
• Develop and manage CMC-related briefing packages, meeting requests, and responses for global health authority interactions (FDA, EMA, MHRA, PMDA, etc.).
• Ensure consistent interpretation of global CMC regulations and guidance; anticipate regulatory trends and risks.
Required Qualifications
• Advanced degree in a relevant scientific discipline (PhD strongly preferred; MS/BS with significant experience considered).
• Typically 12-15+ years of relevant experience in CMC regulatory affairs within biotech/pharma (biologics, small molecules, cell/gene therapy, or combination products-tailor as needed).
• Demonstrated success leading CMC strategy and authoring/reviewing Module 3 for major global submissions (IND/CTA and at least one marketing application strongly preferred).
• Deep knowledge of global CMC regulations and guidances (ICH Q-series, regional requirements, post-approval change frameworks).
• Proven ability to lead cross-functional teams and influence senior stakeholders in a matrix environment.
• Excellent writing, communication, and executive presentation skills.
• You have demonstrated curiosity and adaptability in adopting AI-powered tools and technologies
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.
Salary
$320,000-$350,000 USD
Apply tot his job
Apply To this Job
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. At BridgeBio, we value curiosity and experimentation-including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.
What You'll Do
The Executive Director, Regulatory CMC provides strategic and operational leadership for global CMC regulatory activities across development and (as applicable) commercial products. This role partners closely with CMC, Quality, Technical Operations, Clinical, and Regulatory Affairs leadership to define regulatory CMC strategy, ensure high-quality submissions, and enable product development, licensure, and lifecycle management.
Responsibilities
CMC Regulatory Strategy & Leadership
• Define and execute global CMC regulatory strategies for investigational and marketing applications (e.g., IND/CTA/IMPD/MAA/NDA) and lifecycle changes.
• Serve as the primary CMC regulatory lead for one or more programs and/or as functional head for Regulatory CMC.
• Provide leadership, coaching, and development for Regulatory CMC staff and contractors; build scalable processes as the portfolio grows.
Submissions & Health Authority Interactions
• Lead preparation, review, and approval of CMC sections for regulatory submissions (Module 3, quality overall summaries, responses to information requests).
• Develop and manage CMC-related briefing packages, meeting requests, and responses for global health authority interactions (FDA, EMA, MHRA, PMDA, etc.).
• Ensure consistent interpretation of global CMC regulations and guidance; anticipate regulatory trends and risks.
Required Qualifications
• Advanced degree in a relevant scientific discipline (PhD strongly preferred; MS/BS with significant experience considered).
• Typically 12-15+ years of relevant experience in CMC regulatory affairs within biotech/pharma (biologics, small molecules, cell/gene therapy, or combination products-tailor as needed).
• Demonstrated success leading CMC strategy and authoring/reviewing Module 3 for major global submissions (IND/CTA and at least one marketing application strongly preferred).
• Deep knowledge of global CMC regulations and guidances (ICH Q-series, regional requirements, post-approval change frameworks).
• Proven ability to lead cross-functional teams and influence senior stakeholders in a matrix environment.
• Excellent writing, communication, and executive presentation skills.
• You have demonstrated curiosity and adaptability in adopting AI-powered tools and technologies
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.
Salary
$320,000-$350,000 USD
Apply tot his job
Apply To this Job