HUTCHMED · 1 month ago
Director - Executive Director, Regulatory Affairs, CMC
Florham Park, NJ
Full-time
Hybrid
Director/Executive
10+ years expHUTCHMED is focused on developing innovative global registration strategies for their pipeline. The Regulatory Affairs CMC Director/Senior Director/Executive Director will lead the international Regulatory Affairs CMC team and support the development of global CMC regulatory registration strategies for successful approval of biologics and chemical drug products.
BiopharmaBiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
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
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
Qualification
Required
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
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
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
Preferred
Post-approval experience or ADC or antibody projects experience is a plus
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
Company
HUTCHMED
HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company.
5001-10000 employees
Funding
Current Stage
Public CompanyTotal Funding
$220.2MKey Investors
CPP InvestmentsGeneral AtlanticSBCVC
2020-11-17Post Ipo Equity· $100M
2020-06-25Post Ipo Equity· $100M
2010-12-21Series Unknown· $7.7M
Leadership Team
Johnny Fung
Acting Chief Executive Officer
Simon To
Executive Director and Chairman
Recent News
2026-01-16
2026-01-07
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