Associate Director, Regulatory CMC (Small Molecule)

Role Summary

Associate Director, Regulatory CMC (Small Molecule) – BeOne seeks an experienced regulatory professional to manage and complete CMC-related regulatory submissions and HA interactions, developing strategies and leading cross-functional collaboration to meet aggressive project timelines.

Responsibilities

• Lead, develop and implement small molecule CMC regulatory strategies and author CTD CMC sections to ensure on-time, high-quality global submissions for investigational, market, and post-approval applications.
• Develop regulatory strategy and prepare timely responses to CMC regulatory questions, pre-meeting packages, and interactions with Health Authorities for assigned projects.
• Collaborate with cross-functional leads and communicate CMC regulatory strategies for assigned projects.
• Lead regulatory risk assessment, identify key CMC regulatory issues and mitigation activities throughout the product life cycle; escalate critical issues to senior management promptly.
• Lead or contribute to development of internal small molecule CMC regulatory guidance and working instructions.
• Ensure proper CMC regulatory assessments and actions are taken when recalls or product complaints arise during the product lifecycle for the assigned project.
• Provide CMC regulatory review for clinical protocols and investigator brochures for the assigned project.
• Provide comments on new global guidance through the company’s commenting process.

Qualifications

• 8+ years of related pharmaceutical or biopharmaceutical regulatory CMC experience.
• BA/BS in scientific disciplines required; MS/PhD preferred.
• Proven track record of Health Authority interactions, CTA, NDA/MAA submissions, post-approval preparation, submission, and responses to HA queries.
• In-depth knowledge of ICH, US/EU regulatory requirements; knowledge of rest-of-world regulatory requirements and GMP is a plus.
• Demonstrated leadership as a people manager.
• Experience authoring complex CTD M2 and M3 sections and lifecycle management.
• Scientific background with expertise in at least one area of pharmaceutical development (chemical process, formulation, manufacturing, QC, QA, etc.).
• Excellent oral and written communication skills; detail-oriented, self-motivated, and comfortable with broad responsibilities in a fast-paced environment.

Skills

• Regulatory strategy development
• CTD/M2/M3 documentation
• HA interactions and submissions
• Risk assessment and mitigation
• Cross-functional collaboration
• Regulatory guidance and process improvement

Education

• BA/BS in scientific disciplines; MS/PhD preferred.

Additional Requirements

• Travel: As needed.