Associate Director, Regulatory CMC

Location: This position may be performed remotely but requires flexibility and a willingness to travel as needed. 

Position Summary 

The Associate Director, Regulatory CMC will be responsible for the planning, preparation, and execution of Chemistry, Manufacturing, and Controls (CMC) regulatory activities for investigational and commercial products, including small molecule and antisense oligonucleotide (ASO) programs. This role will work closely with cross-functional partners and external vendors to support global regulatory submissions, health authority interactions, and lifecycle management activities. 

The ideal candidate is a hands-on regulatory professional with strong CMC technical knowledge, a proactive ownership mindset, and a commitment to excellence, who thrives in a fast-paced biotech environment, takes full accountability for assigned programs, effectively partners with cross-functional teams, and consistently delivers high-quality, scientifically sound, and regulatory-compliant outcomes. 

Primary Responsibilities 

• Support development and execution of CMC regulatory strategies for investigational and commercial small molecule and ASO programs, under the direction of the Senior Director. 
• Author, compile, and review CMC sections of regulatory submissions, including INDs, IMPDs, NDAs, BLAs, amendments, and post-approval supplements. 
• Coordinate CMC content development with Quality, Analytical, Development, and Commercial Manufacturing teams. 
• Support health authority interactions including briefing documents and information request responses. 
• Maintain regulatory compliance for CMC activities supporting clinical and commercial supply. 
• Assist with post-approval change management, comparability assessments, manufacturing changes, and technology transfers. 
• Manage external consultants, CMOs, CROs, and regulatory vendors. 

Qualifications and Key Success Factors 

• Bachelor’s, Master’s, or Ph.D. in Chemistry, Pharmaceutical Sciences, Chemical Engineering, Biochemistry, or another relevant scientific discipline; 10+ years of progressively responsible experience in Regulatory CMC and/or technical CMC, or an equivalent combination of advanced education and experience. 
• Demonstrated technical CMC expertise gained through hands-on experience as a subject matter expert in one or more CMC disciplines (e.g., formulation, analytical development, process development, manufacturing, chemistry, pharmaceutical development, or quality), with the ability to independently interpret complex scientific and manufacturing data and translate technical conclusions into sound regulatory strategies. 
• Extensive hands-on experience preparing, reviewing, and/or managing CMC content for INDs, IMPDs, NDAs, BLAs, and post-approval submissions, with strong knowledge of FDA and global CMC regulatory requirements across development and commercial stages. 
• Experience supporting small molecule drug products; experience with antisense oligonucleotides (ASOs) or other oligonucleotide-based therapies is strongly preferred. 
• Demonstrated leadership of complex CMC regulatory activities, including health authority interactions, and the ability to influence cross-functional teams, build consensus among technical SMEs, and effectively work with external manufacturing, testing, and other development partners. 
• Demonstrated ownership mindset with a proactive, can-do attitude and strong commitment to excellence; takes full accountability for assigned Regulatory CMC programs, anticipates and independently resolves complex issues, and consistently delivers high-quality, scientifically sound, and regulatory-compliant outcomes. 
• Strong project management, organizational, written, and verbal communication skills, with the ability to manage multiple programs and priorities effectively in a fast-paced, cross-functional environment. 
• Proficiency in leveraging AI tools and other digital technologies to enhance document preparation, review, data analysis, and day-to-day Regulatory CMC activities while maintaining scientific judgment, data integrity, confidentiality, and compliance with company policies. 

The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You'll need comfort with screen work, basic hand coordination, and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.