Assocaite Director, CMC Regulatory Affairs

Role Summary

As the Associate Director, Regulatory Affairs (CMC), you will play a key role in executing CMC regulatory activities within our organization. You will be responsible for authoring, reviewing, and coordinating CMC regulatory submissions that enable Spyre to initiate and advance clinical trials. You will also contribute to regulatory strategies by implementing CMC-related plans, ensuring compliance with evolving regulatory requirements, and supporting interactions with global health authorities. You will lead submissions across multiple drug candidates and work closely with Technical Operations, Quality, and external partners to ensure timely and compliant delivery of high-quality regulatory documents.

Responsibilities

• Regulatory Submissions: Author and compile CMC sections of regulatory applications, including INDs, IMPDs, CTAs, amendments, and annual reports.
• Documentation: Draft and maintain high-quality CMC regulatory documents such as Module 2 and 3 summaries, stability reports, and comparability protocols.
• Communication: Support regulatory interactions by preparing responses to CMC-related questions from FDA, EMA, PMDA, and other global health authorities.
• Strategy Implementation: Execute CMC regulatory strategies as defined by regulatory leadership to support clinical trial initiation and advancement.
• Cross-functional Collaboration: Partner with Technical Operations, Quality, Manufacturing, and external vendors to gather, verify, and compile CMC information.
• Process Development: Contribute to the development of templates, processes, and workflows to support efficient and compliant CMC regulatory operations.
• Other duties as assigned.

Qualifications

• Bachelor‚Äôs degree with a minimum of 6+ years of experience in CMC regulatory affairs, including experience with clinical biologics programs or equivalent related experience.
• Hands-on experience authoring and compiling CMC sections of INDs, IMPDs, CTAs, amendments, and related filings.
• Strong knowledge of global CMC clinical regulatory requirements and guidelines, including FDA, EMA, and ICH.
• Experience with biologics, drug-device combination products (e.g., pre-filled syringes, auto-injectors), or diagnostics (companion diagnostics) preferred.
• Excellent attention to detail, technical writing, organizational, and communication skills.
• Ability to manage multiple deliverables and timelines in a fast-paced environment.
• Proficiency with regulatory document management systems.

Skills

• Regulatory strategy and submissions
• CMC documentation and technical writing
• Cross-functional collaboration
• Global health authority interactions
• Regulatory project management

Education

• Bachelor‚Äôs degree (required)

Additional Requirements

• Remote working environment with frequent in-person meetings to address complex problems and build relationships.