BridgeBio

2 months ago

Sr. Director, Regulatory Affairs - CMC

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 15 hours agoStatus: Live

Job Summary

Lead CMC regulatory strategy and execution across development and post-approval programs, serving as a regulatory CMC SME and cross-functional partner. Influences decision-making, supports ROW/global filings (MENA, LATAM, APAC), mentors juniors, and utilizes AI-enabled tools to improve regulatory workflows while ensuring compliance.

Location: San Francisco

Workplace: Remote

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Seniority: Sr. Manager level

Key Responsibilities

•Lead CMC regulatory strategy, planning, and execution for IND/CTA, NDA/MAA, post-approval submissions, and global registrations across development programs
•Partner closely with CMC, Quality, Regulatory Operations, and cross-functional stakeholders to ensure timely, high-quality regulatory submissions aligned with global health authority expectations
•Provide strategic guidance on CMC regulatory risks, change controls, health authority interactions, and submission strategies to support program objectives and regulatory compliance
•Coordinate and review responses to CMC-related health authority requests and ensure regulatory conformance of technical documentation, manufacturing information, validation activities, and labeling content
•Mentor and coach junior team members and provide oversight for vendors and/or assigned staff, including prioritization, feedback, and support for development activities
•Apply AI-enabled tools and digital technologies to improve the efficiency, quality, and consistency of regulatory deliverables while adhering to company policies and data governance standards
•Contribute to global regulatory activities, including ROW submissions (MENA, LATAM, APAC) and coordinating regional filing requirements and strategies

Travel: Low travel

Pay and Benefits

Salary: USD 285,000 - 320,000 annually

Perks:Health Insurance401kEsppEquityAnnual Bonus

Key Requirements

•BA/BS in Chemistry, Pharmaceutical Sciences, Life Sciences, or related field; advanced degree preferred
•Extensive Regulatory Affairs CMC experience with NDA/MAA submissions in pre- and post-approval environments
•Demonstrated experience leading complex global regulatory submissions including ROW (MENA, LATAM, APAC)
•Strong knowledge of global health authority regulations, CMC development, manufacturing processes, and quality documentation standards
•Ability to travel as needed (approximately 10–20%)

Experience:BiopharmaBiotechPharmaceuticals

Education:Bachelor's

Skills:LeadershipCommunicationProblem-solvingCollaborationStrategic thinking

Languages:English

Tech Stack:AIDigital toolsRegulatory information management

Company Brief

BridgeBio

Develops medicines for patients with genetic diseases by advancing targeted therapeutics from discovery through clinical development and commercialization, focusing on genetically defined diseases with high unmet medical need.

Industry: Biotech

Company Size: Large (251 to 1,000 employees)

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: Palo Alto, United States

Founded: 2015

Website LinkedIn

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BridgeBio

2 months ago

Sr. Director, Regulatory Affairs - CMC

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 15 hours agoStatus: Live

Job Summary

Location: San Francisco

Workplace: Remote

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Seniority: Sr. Manager level

Key Responsibilities

•Lead CMC regulatory strategy, planning, and execution for IND/CTA, NDA/MAA, post-approval submissions, and global registrations across development programs
•Partner closely with CMC, Quality, Regulatory Operations, and cross-functional stakeholders to ensure timely, high-quality regulatory submissions aligned with global health authority expectations
•Provide strategic guidance on CMC regulatory risks, change controls, health authority interactions, and submission strategies to support program objectives and regulatory compliance
•Coordinate and review responses to CMC-related health authority requests and ensure regulatory conformance of technical documentation, manufacturing information, validation activities, and labeling content
•Mentor and coach junior team members and provide oversight for vendors and/or assigned staff, including prioritization, feedback, and support for development activities
•Apply AI-enabled tools and digital technologies to improve the efficiency, quality, and consistency of regulatory deliverables while adhering to company policies and data governance standards
•Contribute to global regulatory activities, including ROW submissions (MENA, LATAM, APAC) and coordinating regional filing requirements and strategies

Travel: Low travel

Pay and Benefits

Salary: USD 285,000 - 320,000 annually

Perks:Health Insurance401kEsppEquityAnnual Bonus

Key Requirements

•BA/BS in Chemistry, Pharmaceutical Sciences, Life Sciences, or related field; advanced degree preferred
•Extensive Regulatory Affairs CMC experience with NDA/MAA submissions in pre- and post-approval environments
•Demonstrated experience leading complex global regulatory submissions including ROW (MENA, LATAM, APAC)
•Strong knowledge of global health authority regulations, CMC development, manufacturing processes, and quality documentation standards
•Ability to travel as needed (approximately 10–20%)

Experience:BiopharmaBiotechPharmaceuticals

Education:Bachelor's

Skills:LeadershipCommunicationProblem-solvingCollaborationStrategic thinking

Languages:English

Tech Stack:AIDigital toolsRegulatory information management

Company Brief

BridgeBio

Industry: Biotech

Company Size: Large (251 to 1,000 employees)

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: Palo Alto, United States

Founded: 2015

Website LinkedIn