Associate Director/Senior Manager, RA-CMC(J19660)

职位描述

• Lead/co-lead the development, implementation, and execution of global CMC regulatory strategies for biologics from early development through commercialization and lifecycle management.

• Serve as the Global Regulatory CMC Lead/co-lead on cross-functional project teams, providing strategic regulatory leadership and influencing development, manufacturing, quality, and commercial decisions.

• Lead the preparation, review, and approval of high-quality CMC regulatory submissions, including INDs/CTAs, BLAs/MAAs, supplements, amendments, variations, and responses to Health Authority requests.

• Support the Regulatory CMC aspects of Health Authority interactions, partnering with CMC subject matter experts to develop meeting strategies, briefing materials, and responses to regulatory questions.

• Provide regulatory assessments for manufacturing process changes, analytical methods, control strategies, comparability, technology transfers, and lifecycle management activities.

• Identify regulatory risks and develop proactive mitigation strategies to support product development timelines, product registrations, and regulatory compliance.

• Monitor evolving global CMC regulations, guidance documents, and industry trends, assessing their impact and ensuring organizational compliance.

任职要求

• Bachelor's degree in Biological Sciences, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related scientific discipline; advanced degree (MS, PhD, or PharmD) is preferred.

• Demonstrated experience developing and leading global CMC regulatory strategies for biologic products across multiple phases of development and/or commercialization.

• Extensive knowledge of global CMC regulations, ICH guidelines, and regional regulatory requirements (FDA, EMA, PMDA, NMPA, MHRA, and other international Health Authorities).

• Experience with Health Authority interactions, including preparation for regulatory meetings, briefing documents, and responses to regulatory questions.

• Strong understanding of biologics manufacturing processes, analytical characterization, process validation, comparability, control strategies, and Quality by Design (QbD) principles.

• Demonstrated ability to lead cross-functional teams, influence senior stakeholders, and manage multiple complex global projects simultaneously.

• Strong organizational skills with exceptional attention to detail and a demonstrated ability to prioritize competing deadlines in a fast-paced environment.