Director of RA CMC

• Regulatory CMC Strategy: Develop and execute comprehensive, proactive global CMC regulatory strategies for assigned programs from early development through marketing application and post-approval
• Regulatory Submission Leadership: Serve as the Regulatory CMC Lead for major filings. Author, review, and critically assess high-quality CMC sections for all global regulatory submissions
• Health Authority Interactions: Lead the preparation, coordination, and execution of all CMC-focused interactions with global health authorities
• Expert Guidance on Complex Products: Act as the in-house subject matter expert on global regulatory CMC requirements for complex oligonucleotide-based products, including device-drug combination products
• Strategic Liaison & Collaboration: Serve as the primary regulatory liaison between the CMC department and the broader Regulatory Affairs team

• Advanced degree (Ph.D. preferred, M.S. required) in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or a related field
• Minimum of 10 years of combined experience in CMC development (process, analytical, formulation) and Regulatory Affairs CMC within the pharmaceutical industry
• Experience with device-drug combination products is a plus
• Proven track record of successfully developing and implementing global CMC regulatory strategies from Phase 1 through approval
• Extensive experience authoring CMC sections for major filings (IND/NDA) and leading health authority interactions
• Comprehensive knowledge of US, EU, and ICH CMC guidelines
• Must understand the scientific and technical nuances of oligonucleotide synthesis, purification, analytics, and stability
• Outstanding written and verbal communication skills in English are mandatory
• Demonstrated ability to think strategically, anticipate regulatory challenges, and develop innovative solutions
• Strong leadership presence with the ability to influence and align cross-functional teams without direct authority
• Excellent project management and organizational skills

Experience with device-drug combination products is a plus