Senior Director, Regulatory CMC

This is a fully remote position, open to applicants in California.

📋 Description

• Direct the global CMC regulatory strategy and execution for small molecule and biological initiatives throughout all phases of development.

• Lead the creation of global CMC regulatory submissions, which include IND/CTA, NDA/BLA, and MAA applications.

• Manage the comprehensive preparation, review, and finalization of CMC dossiers.

• Formulate and execute regulatory CMC strategies, with an emphasis on late-stage development and post-approval GMP-related regulatory support.

• Act as the main CMC liaison for interactions with health authorities such as NMPA, CDE, FDA, and EMA.

• Facilitate pre-IND/NDA/BLA meetings and provide responses to regulatory inquiries.

• Conduct regulatory risk assessments, pinpoint critical CMC issues, and establish mitigation plans.

• Offer strategic regulatory CMC advice to cross-functional project teams.

• Ensure compliance of regulatory submissions with relevant regulations and guidelines.

• Lead and oversee a team of CMC regulatory professionals, including mentoring, performance management, and career development.

• Create internal regulatory CMC guidelines, work instructions, and process enhancements.

• Stay updated on regulatory requirements, guidelines, and technical advancements.

• Collaborate with QA/QC, R&D, manufacturing, and external partners.

⛳️ Requirements

• A PhD in a scientific discipline with eight years of regulatory experience, or a comparable blend of education, training, and experience.

• RAC certification is advantageous.

• Exceptional verbal and written communication skills in both English and Chinese.

• Capability to clearly and concisely articulate complex regulatory matters.

• Profound scientific understanding of small molecule and biologics CMC principles, including development processes, manufacturing, and controls.

• Comprehensive knowledge of international regulatory requirements and guidelines, including ICH, NMPA/CDE, FDA, and EMA.

• Demonstrated experience with global submissions.

• Proven history of leading CMC regulatory submissions, including INDs, NDAs, and BLAs.

• Successful engagements with health authorities.

• Evidence of leadership success as a people manager, with experience in team building and development.

• Strong strategic thinking, creative problem-solving, and decision-making skills.

• Detail-oriented with robust project management, negotiation, and interpersonal abilities.

🏝️ Benefits

• Sign-on bonus.

• Restricted stock units.

• Discretionary awards.

• Medical benefits.

• Financial benefits.

• 401(k) eligibility.

• Paid vacation.

• Paid sick time.

• Paid parental leave.