Sr. Manager/Associate Director, CMC Regulatory Sciences

What You'll Do

Senior Manager / Associate Director, CMC Regulatory Sciences reports to the head of CMC Regulatory Sciences and will support BridgeBio Pharma and its subsidiaries, including Eidos Therapeutics, Calcilytix Therapeutics, and ML Bio Solutions. This position will work with CMC technical teams (Drug Substance, Drug Product, and Analytical Development) and Regulatory Affairs to design and implement control strategies in alignment with ICH and regional regulatory requirements throughout the product lifecycle. This position will be responsible for authoring and reviewing drug substance and drug product sections of global clinical trial applications and supplements, marketing authorization applications, and post-approval changes, as well as responding to health agency queries and information requests.

Responsibilities

• Collaborate with small molecule CMC technical teams to design and implement drug substance and drug product control strategies to meet current and evolving regulatory requirements throughout a program’s life cycle.
• Author and review technically complex drug substance and drug product sections of clinical trial applications and supplements (e.g., IND, IMPD, CTA), and marketing authorization applications and post-approval changes/variations (e.g., NDA, MAA, JNDA) in collaboration with subject matter experts and stakeholders.

• Author responses to health authority queries and information requests related to Quality sections of clinical and marketing approval applications.

• Prepare and maintain quality risk assessments, including but not limited to, identification and control of (potentially) mutagenic impurities in accordance with ICH M7, elemental impurities in accordance with ICH Q3D, and nitrosamines in accordance with global regulatory guidelines.

• Advise development teams on the selection and justification of regulatory starting materials, establishment of specifications, and characterization of manufacturing processes.

• Identify key regulatory issues with potential impact across multiple projects. Raise awareness with and appropriately influence affected teams.

• Apply AI-enabled tools and digital technologies to improve the efficiency, quality, and consistency of regulatory submissions while adhering to company policies and data governance standards
• Interface with International Regulatory Affairs, CMC Regulatory Affairs, Supply Chain Management, and CMC technical teams on global launch sequence, filing strategies, and regional filing requirements which may impact CMC manufacturing timelines, stability, and/or control strategies.

Where You'll Work

This is a hybrid role and preference will be given to candidates local to San Francisco and able to work in-office 2–3x per week. A US-based fully remote role may be considered for the right candidate.

Who You Are

• PhD with 7+ years relevant experience, or BS/MS with 10+ years relevant experience.
• Combination of experience in CMC development and regulatory authoring is preferred.  Background in drug product or analytical development is a plus.
• Familiarity with FDA, EMA, and ICH guidelines for INDs/NDAs/MAAs. Thorough understanding of cGMP, quality and regulatory requirements for drug substance and drug product manufacturing. Ability to interpret regulatory requirements and collaborate with development and/or commercial teams to create actionable plans to meet these requirements.
• Working knowledge of analytical method development, validation, and global stability requirements.
• Ability to develop strategies, make decisions, and advise technical teams in ambiguous regulatory landscapes.
• Strong attention to detail and time management skills. Excellent oral and written communication skills. Excellent organizational skills and demonstrated ability to deliver on multiple projects simultaneously with tight timelines.
• Ability to effectively interface with and/or manage highly skilled internal staff.  Ability to work independently as well as in a team. Ability to build good working relationships.