Director - Executive Director, Regulatory Affairs, CMC

PRIMARY FUNCTION

• The mission of HUTCHMED International Regulatory Affairs is to develop innovative global registration strategies that advance our pipeline through approval in US, EU, and other countries.

• In this position, the Regulatory Affairs CMC Director/Senior Director/Executive Director will lead the international Regulatory Affairs CMC team and support the development of sound global CMC regulatory registration strategies to support HUTCHMED’s pipeline for successful approval of our biologics and chemical drug products within US, EU, and other countries.

• Lead CMC regulatory strategy development and implementation that incorporates risk identification and mitigation at various stages of the product life cycle.

• Work cross-functionally and serve as a liaison between the clinical development teams and other HUTCHMED departments, including CMC and Quality.

• Direct and manage regulatory CMC activities and dossier content for US, EU, and other countries within timelines and in accordance with global regulatory expectations and requirements for biologics or chemical molecules.

• Provide strategic CMC counsel throughout the CMC regulatory process to development teams in US, EU, and China.

MAJOR RESPONSIBILITIES AND DUTIES

• Actively collaborates with development teams in China to develop and execute robust regulatory CMC strategies and risk migration for product development and registration;

• Lead and manage the development and preparation of US and EU CMC-related submission documents for investigational new drug applications (e.g., INDs, CTAs), Biologics license applications (e.g., BLAs, MAAs), and briefing documents that meet current regulatory standards and are of high quality, to enable regulatory approval on the first review cycle;

• Evaluates regulatory impact of manufacturing changes for related submissions and communicates changes to appropriate areas to ensure compliance with required standards;

• Lead interactions with US and EU regulatory agencies on CMC-related topics in collaboration with development teams;

• Coordinate with teams within HUTCHMED and CRO/CDMO partners to address any CMC questions from health authorities in the US, EU, and other countries;

• Ensure compilation of electronic CMC submissions according to current regulatory standards;

• Provide regulatory oversight in developing and implementing SOP’s;

• Acquires and maintains thorough knowledge of current regulatory CMC requirements; stays abreast of regulatory CMC changes affecting products/projects.

QUALIFICATIONS

• BS degree in a scientific discipline (e.g., Pharmaceutical Science, Biotechnology, Biochemistry, Biology, Chemistry, etc.) is required, along with a minimum of 12 years of experience in the pharmaceutical/biotechnology industry with at least 6 years in a regulatory CMC role, OR

• Advanced degree, e.g., PhD, PharmD, and 10 years in the biopharmaceutical/biotechnology industry experience with at least 6 years in a regulatory CMC role

• Demonstrated experience with US and EU CMC submissions, successfully achieved IND filing and NDA/BLA filing, briefing documents, and response to agency queries

• Post-approval experience or ADC or anitibody projects experience is a plus

• Thorough scientific and manufacturing knowledge, understanding of regulatory policy, GMP, and ICH guidelines

• Good leadership, organizational, and problem-solving skills

• Excellent written and oral communication skills

• Sensitivity for multicultural/multinational environment and understanding of global biopharmaceutical development process

• Proficiency on key operations systems, including eCTD submissions software and electronic gateway submissions, a plus

• Familiarity with infrastructure software, such as EDMS/RIMS/eCTD a plus

• Knowledge of EU regulatory requirements a plus

• Ability to manage priorities and workflow, managing multiple projects and meeting deadlines

• Acute attention to detail

• Good judgement with the ability to make timely and sound decisions