Associate Director, Regulatory CMC (Small Molecule)

Role Summary

Associate Director, Regulatory CMC (Small Molecule) responsible for managing, evaluating, and completing regulatory projects related to CMC. Develop strategies, plan and draft regulatory submissions, and interact with health authorities to meet project timelines. Support cross-functional teams on CMC regulatory strategies and process optimizations.

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 timely.
• 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 product lifecycle for the assigned project.
• Provide CMC regulatory review for clinical protocols and investigator brochures, etc., for the assigned project.
• Provide comments on new global guidance through the company‚Äôs commenting process.

Qualifications

• 8+ years of related pharmaceutical or biopharmaceutical industry regulatory CMC experience.
• BA/BS in scientific disciplines required; MS/PhD preferred.
• Proven record of leading Health Authority interactions, CTA, NDA/MAA, post-approval preparation, submission, and responses to HA queries.
• In-depth knowledge of ICH requirements and US/EU regulatory requirements; knowledge of rest of world regions and GMP regulation is a plus.
• Demonstrated leadership as a people manager.
• Experience in authoring complex technical documents, CTD M2 and M3 sections, and life cycle management.
• Educational background in scientific disciplines 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
• CMC regulatory submissions
• Health Authority interactions
• CTD M2/M3 documentation
• Lifecycle management
• Risk assessment and mitigation
• Cross-functional collaboration

Education

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

Additional Requirements

• Travel: As needed.