Sr. Manager/Associate Director, CMC Regulatory Sciences
BridgeBio
August 21, 2026
Remote friendly (San Francisco, CA)
United States
Corporate Functions
Responsibilities:
- Design and implement drug substance and drug product control strategies with CMC technical teams to meet evolving regulatory requirements throughout the product lifecycle.
- Author and review complex drug substance/drug product sections for IND, IMPD, CTA, and marketing authorization applications and post-approval changes/variations (NDA, MAA, JNDA) with SMEs and stakeholders.
- Author responses to health authority quality-related queries and information requests.
- Prepare and maintain quality risk assessments for mutagenic impurities (ICH M7), elemental impurities (ICH Q3D), and nitrosamines.
- Advise on regulatory starting materials, specifications, and characterization of manufacturing processes.
- Identify key regulatory issues across multiple projects and influence affected teams.
- Use AI-enabled tools/digital technologies to improve submission efficiency, quality, and consistency while following company policies and data governance.
- Coordinate with International Regulatory Affairs, CMC Regulatory Affairs, Supply Chain, and CMC teams on global launch sequence, filing strategies, and regional filing requirements.
Qualifications:
- PhD with 7+ years relevant experience, or BS/MS with 10+ years relevant experience.
- Preferred: CMC development + regulatory authoring; plus drug product or analytical development experience.
- Familiarity with FDA/EMA/ICH guidance for INDs/NDAs/MAAs; strong cGMP/regulatory understanding for drug substance and drug product.
- Working knowledge of analytical method development/validation and global stability requirements.
- Strong communication, time management, organization, and ability to advise in ambiguous regulatory environments.
Benefits (explicitly stated):
- 401(k) match, ESPP, employer-paid medical/dental/vision (with dependents), HSA (with annual employer contributions) and FSA, hybrid flexibility, and paid medical/parental leave.
- Design and implement drug substance and drug product control strategies with CMC technical teams to meet evolving regulatory requirements throughout the product lifecycle.
- Author and review complex drug substance/drug product sections for IND, IMPD, CTA, and marketing authorization applications and post-approval changes/variations (NDA, MAA, JNDA) with SMEs and stakeholders.
- Author responses to health authority quality-related queries and information requests.
- Prepare and maintain quality risk assessments for mutagenic impurities (ICH M7), elemental impurities (ICH Q3D), and nitrosamines.
- Advise on regulatory starting materials, specifications, and characterization of manufacturing processes.
- Identify key regulatory issues across multiple projects and influence affected teams.
- Use AI-enabled tools/digital technologies to improve submission efficiency, quality, and consistency while following company policies and data governance.
- Coordinate with International Regulatory Affairs, CMC Regulatory Affairs, Supply Chain, and CMC teams on global launch sequence, filing strategies, and regional filing requirements.
Qualifications:
- PhD with 7+ years relevant experience, or BS/MS with 10+ years relevant experience.
- Preferred: CMC development + regulatory authoring; plus drug product or analytical development experience.
- Familiarity with FDA/EMA/ICH guidance for INDs/NDAs/MAAs; strong cGMP/regulatory understanding for drug substance and drug product.
- Working knowledge of analytical method development/validation and global stability requirements.
- Strong communication, time management, organization, and ability to advise in ambiguous regulatory environments.
Benefits (explicitly stated):
- 401(k) match, ESPP, employer-paid medical/dental/vision (with dependents), HSA (with annual employer contributions) and FSA, hybrid flexibility, and paid medical/parental leave.