Job Description

Primary Function:

Responsible for leading the global CMC regulatory strategy and execution for both small molecule and biological projects across all phases of development, including strategy, dossier preparation and submissions, and responses to the regulatory agencies' requests.

Major Responsibilities and Duties:

• Lead the preparation of global CMC regulatory submissions for both small molecules and biologics, including IND/CTA, NDA/BLA/MAA applications. Oversee the end-to-end CMC dossier preparation, review, and finalization, ensuring scientific soundness, data integrity, and regulatory compliance across all product modalities.
• Develop and implement comprehensive regulatory CMC strategies to facilitate the progress of programs in all phases of development, with focus on late-stage development and post-approval regulatory support for all GMP-related activities (change control, deviation regulatory evaluation, etc.).
• Act as the primary CMC contact for interactions with health authorities (e.g., NMPA, CDE, FDA, EMA) on CMC-related issues, including leading pre-IND/NDA/BLA meetings and responses to regulatory questions.
• Lead regulatory risk assessment, identify key CMC issues, and define mitigation activities throughout the product lifecycle.
• Provide strategic regulatory CMC guidance to cross-functional project teams to ensure development activities comply with relevant guidelines and governmental regulations.
• Ensure that the content and format of regulatory submissions comply with applicable regulations and guidelines (ICH, NMPA, FDA, EMA, etc.).
• Lead and manage a team of CMC regulatory professionals, including mentoring, performance management, and career development.
• Contribute to the development of internal regulatory CMC guidance, working instructions, and process improvements to enhance dossier quality and review efficiency.
• Maintain up-to-date knowledge of evolving regulatory requirements, guidelines, and technical trends in both small molecule and biologics CMC domains.
• Collaborate effectively with internal stakeholders (e.g., QA/QC, R&D, manufacturing) and external partners to deliver high-quality dossiers and support business priorities.

Qualifications

REQUIRED:

• PHD in scientific discipline with eight years of regulatory experience; or equivalent combination of education, training and experience. RAC certification is a plus.
• Excellent verbal and written communication skills in both English and Chinese, with the ability to articulate complex regulatory issues clearly and concisely.

PREFERRED:

• Deep scientific understanding of both small molecule and biologics CMC principles, including development processes, manufacturing, and controls.
• Thorough knowledge of international regulatory requirements and guidelines, including ICH, NMPA/CDE, FDA, and EMA, with proven experience in global submissions.
• Proven track record of leading CMC regulatory submissions (INDs, NDAs, BLAs) and successful interactions with health authorities.
• Demonstrated leadership success as a people manager with experience in building and developing teams.
• Strong strategic thinking, creative problem-solving, and decision-making abilities.
• Detail-oriented with strong project management, negotiating, and interpersonal skills.

Additional Information

The pay range for this position at commencement of employment is expected to be between $258k and $320K/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Disclaimer: This description is not intended to be construed as an exhaustive list of duties, responsibilities, or requirement for the position. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.