Senior Director, CMC Regulatory

Essential Duties And Responsibilities

• Lead the development and execution of CMC regulatory strategies, working in close collaboration with cross-functional teams to ensure regulatory strategies are aligned with program objectives and timelines
• Proactively manage regulatory CMC aspects of programs to ensure on-time delivery of global, high-quality submissions across all development-stage programs
• Manage regulatory interactions with global health authorities, including meeting preparation and participation, responses to questions, and negotiations
• Provide regulatory expertise on CMC strategies to cross-functional teams, anticipating regulatory concerns, and proposing innovative solutions
• Evaluate proposed manufacturing and quality changes for impact to ongoing and existing submissions and provide strategic regulatory guidance for optimal implementation of changes
• Help develop and implement department practices, policies, processes, and SOPs
• Manage internal or external staff as needed

Qualifications And Preferred Skills

• Bachelor’s degree in scientific discipline required, advanced degree in Chemistry preferred
• Minimum of 10 years industry experience with majority of experience in CMC Regulatory Affairs or related roles
• Minimum of 5 years of experience with global early and late phase submissions (IND/IMPD and NDA/MAA, amendments, and annual reports) and health authority interactions
• Prior small molecule experience preferred
• Excellent knowledge of FDA, EMA and ICH regulatory guidelines and regulations
• Collaborate and communicate well with all levels of employees, including peers, executives and cross-functionally
• Strong interpersonal, communication (oral and written), and organizational skills
• Able to handle and prioritize multiple assignments, and work in a fast-paced environment