Global CMC Regulatory Strategy Director

HUTCHMED; Florham Park (NJ); On-site; USD 170,000 - 230,000; Full time

Job summary

HUTCHMED is seeking a Regulatory Affairs CMC Director to lead the international CMC team and shape global CMC strategies to support the pipeline of biologics and chemical drug products for the US, EU, and other countries.

You will direct regulatory CMC activities, manage submissions (INDs, BLA/NDA) and maintain up-to-date knowledge of ICH, GMP, and EDMS/RIMS workflows, while collaborating with development teams, CMC, Quality, and external partners.

Qualifications

• BS or higher in pharmaceutical science, biotech, biology or chemistry with regulatory CMC experience.
• 10+ years in pharma/biotech with at least 6 years in regulatory CMC.
• Experience with US/EU CMC submissions and NDA/BLA filings.
• Familiarity with GMP, ICH guidelines and global regulatory policy.
• Leadership with ability to manage multiple projects and deadlines.

Responsibilities

• Lead international CMC regulatory strategy development and execution.
• Direct and manage CMC activities and dossier content for US, EU, and other countries.
• Collaborate with development teams, CMC, and Quality; liaise with regulators.
• Prepare US/EU CMC submission documents (INDs, CTAs, BLAs, MAAs) and briefing materials.
• Ensure electronic CMC submissions and maintain SOPs; stay current on CMC requirements.

Skills

Leadership

Regulatory acumen

Strategic thinking

Communication

Problem solving

Multitasking

Education

BS in a scientific discipline

Advanced degree (PhD/PharmD)

Tools

eCTD submissions software

EDMS/RIMS

Electronic gateway submissions

Job description

HUTCHMED is seeking a Regulatory Affairs CMC Director to lead the international CMC team and shape global CMC strategies to support the pipeline of biologics and chemical drug products for the US, EU, and other countries.

You will direct regulatory CMC activities, manage submissions (INDs, BLA/NDA) and maintain up-to-date knowledge of ICH, GMP, and EDMS/RIMS workflows, while collaborating with development teams, CMC, Quality, and external partners.