Director/Sr. Director, Regulatory Affairs - CMC @BridgeBio Pharma

[Hiring] Director/Sr. Director, Regulatory Affairs - CMC @BridgeBio Pharma

Mar 12, 2025 - BridgeBio Pharma is hiring a remote Director/Sr. Director, Regulatory Affairs - CMC. 💸 Salary: $210,000 - $315,000 usd. 📍Location: Europe, USA, Canada.

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Role Description

This experienced Regulatory Affairs team member will provide CMC regulatory expertise and support for development project work, including oversight of CMC regulatory submissions working closely with CMC QA and regulatory stakeholders.

Represent CMC Regulatory Affairs on CMC and Regulatory sub-teams with respect to RA CMC deliverables for Rest of World (ROW) filing.
Ensure the planning, development, and finalization of high-quality CMC documentation designed to meet regulatory requirements.
Oversee US post-approval submissions and ex-US global registrations as applicable.
Develop strong relationships with various departments and different management levels.
Scope ranges from early clinical development through submission and maintenance of license applications.

Responsibilities

Work closely with CMC and Quality colleagues to develop CMC regulatory submission strategies for ROW and other regions.
Plan and track the completion of CMC content for NDA/MAA and IND/CTA submissions.
Coordinate responses to CMC information requests from health authorities.
Ensure documented quality control (QC) checks are performed for CMC documents before submission.
Collaborate with CMC Team and Quality to ensure regulatory conformance of technical documentation.
Ensure communication and alignment on CMC regulatory strategy with internal key stakeholders.
Proactively identify potential risks to programs and contribute to solutions.
Ensure that CMC-related changes are reported to authorities per regulatory requirements.
Responsible for regulatory impact assessments for CMC change control.
Lead preparation for health authority meetings with CMC focus.
Work closely with the regulatory operations group to ensure proper archival of CMC-related correspondence.
Maintain knowledge of current and emerging CMC regulatory requirements and communicate relevant topics to colleagues.
Oversee responsibilities for department staff and vendors as agreed with the manager.
Support other Regulatory Affairs functions as needed.

Qualifications

BA/BS degree in chemistry or similar required, post-graduate degree preferred.
Successful experience leading Regulatory CMC activities for multiple regulatory filings in pre-and post-approval settings.
Excellent oral and written communication skills with proven ability to analyze and organize information logically.
Thorough knowledge of drug development, health authority regulations and guidelines, CMC and Quality documentation standards.
Strong leadership and project management skills, ability to work independently, multi-task, and work effectively under pressure.
Excellent interpersonal, active listening, and influencing skills.
Strong collaboration, teamwork, organizational skills, and attention to detail.
Prior management experience preferred.

Benefits

Patient Days to hear directly from individuals living with the conditions we are seeking to impact.
A culture inspired by values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak.
An unyielding commitment to always putting patients first.
A de-centralized model that enables program teams to focus on advancing science and helping patients.
A place where you own the vision – both for your program and your own career path.
A collaborative, fast-paced, data-driven environment.
Access to learning and development resources.
Robust and market-competitive compensation & benefits package.
Flexible PTO.
Rapid career advancement for strong performers.
Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas.
Partnerships with leading institutions.
Commitment to Diversity, Equity & Inclusion.

Salary

$210,000 — $315,000 USD

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📍	Be aware of the location restriction for this remote position: Europe, USA, Canada
‼	Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.

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Director/Sr. Director, Regulatory Affairs - CMC @BridgeBio Pharma

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Salary 💸 $210,000 - $315,000 usd	Remote Location Europe, USA, Canada
Job Type unspecified	Posted Mar 12, 2025

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📍	Be aware of the location restriction for this remote position: Europe, USA, Canada
‼	Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.

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[Hiring] Director/Sr. Director, Regulatory Affairs - CMC @BridgeBio Pharma

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