Senior Manager – Regulatory Affairs

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $160k - $225k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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BridgeBio

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2015

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

BridgeBio is a biotechnology company focused on designing transformative medicines for patients with genetic diseases. It employs a novel approach to drug development by integrating finance with science to deliver solutions as efficiently as possible. The company is committed to developing not only life-changing drugs but also leaders in the field, encouraging hands-on engagement and the pursuit of innovation. BridgeBio actively seeks investment to help achieve its mission of providing solutions for unique patient populations with unmet needs. Headquartered in Palo Alto, CA, BridgeBio emphasizes bridging the gap between scientific advancements and patient care.

📋 Description

• Develop and execute regional regulatory strategies for development programs • Provide regional regulatory guidance and oversight for product development and registration strategies, including nonclinical and clinical development • Plan, compile, review, and submit regulatory documents, including initial INDs, CTAs, NDAs, amendments, and supplements • Represent Regulatory at cross-functional team meetings • Lead study-related regulatory activities and provide strategic guidance on study-level decisions • Own global study-level regulatory activities, including CTA and IND submissions, investigator document package reviews and approvals, and FDA submissions • Track regulatory and ethics submissions and approvals across studies • Facilitate FDA and other Health Authority meetings with Regulatory leadership • Collaborate with project teams to plan, review, finalize, and sign off regulatory submissions • Develop, maintain, and communicate regulatory submission timelines • Review protocols, ICFs, IBs, CSRs, and DSURs for compliance with ICH, FDA, EMA, and other applicable regulations • Coordinate with CROs and vendors to plan and finalize health authority submissions • Manage regulatory agency queries and commitments, coordinate written responses with subject matter experts, and provide status updates • Contribute to global regulatory submissions and strategic planning • Maintain regulatory databases, submission logs, and correspondence logs • Review, write, and present regulatory guidelines and SOPs • Maintain current knowledge of US and global regulations, guidance, and standards for drug development and product registration

🎯 Requirements

• BA/BS degree in the biological or physical sciences; advanced degree (e.g., PharmD or PhD) preferred • Relevant pharmaceutical industry experience, including regulatory affairs experience • Minimum of 3 years of industry experience generally required for the Senior Manager level; greater experience and scope expected at the Associate Director level • An equivalent combination of education and experience may be considered • Knowledge of US FDA and international pharmaceutical guidance and regulations, including 21 CFR, ICH, GCP, GMP, and EMA • Knowledge of the drug development process and industry-standard practices • Demonstrated experience supporting eCTD-formatted submissions, including INDs, NDAs/BLAs, MAAs, annual reports, amendments, and supplements • Experience coordinating or supporting responses to health authorities or other critical submission projects while maintaining agreed timelines • Proficient written, oral, and interpersonal communication in English • Ability to collaborate with regulatory colleagues and throughout the development organization • Capability to provide strategic guidance on regulatory and program-related issues • Ability to problem solve unexpected problems or roadblocks • High attention to detail; ability to organize, prioritize, and delegate assigned projects • Experience interacting with CROs in managing US eCTD IND submissions and ex-US CTAs toward clinical trial activations preferred • Proficient user of Microsoft Office (Word, Excel, PowerPoint) • Experience using Veeva electronic document management systems and document review tools

🏖️ 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 • Skill development and internal mobility opportunities • 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

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