Associate Director/ Director, CMC Regulatory Affairs
Scorpion Therapeutics, Redwood City, California, United States, 94061
Role Summary
Associate Director/Director, CMC Regulatory Affairs will lead and execute regulatory activities for the ECO Synthesis platform and associated manufacturing activities. The role advances engagement with the FDA Emerging Technologies Program, supports pursuit of FDA Advanced Manufacturing Technology Designation, and prepares for GMP manufacturing and regulatory submissions including DMFs and IND support. The position also drives partner collaboration by supplying information and co-developing Module 3 CMC information for partner submissions. Responsibilities
Regulatory Strategy & Leadership
Develop and implement CMC regulatory strategies for the ECO Synthesis platform and GMP siRNA manufacturing. Lead interactions with regulatory agencies, including ongoing discussions with the FDA Emerging Technologies Team. Drive efforts toward achieving FDA Advanced Manufacturing Technology Designation.
Documentation & Submissions
Prepare and manage CMC sections of regulatory submissions including INDs, DMFs, and amendments. Support therapeutic developer customers by providing high-quality documentation for Module 3 of their INDs. Ensure alignment of regulatory documentation with ISO 9001 and future GMP standards.
Cross-functional Collaboration
Partner with Process Development, Quality, Manufacturing, and Business Development teams to ensure regulatory compliance and readiness. Provide regulatory guidance during the design and construction of the GMP manufacturing facility.
Compliance & Quality
Ensure regulatory compliance with evolving FDA and global regulatory expectations for advanced manufacturing technologies. Maintain awareness of regulatory trends and proactively assess their impact on company strategy.
Qualifications
Required: Advanced degree in life sciences, chemistry, or related field (PhD, PharmD, MS preferred). Required: 8+ years of experience in CMC regulatory affairs within the biotechnology or pharmaceutical industry. Required: Proven experience with regulatory submissions (INDs, DMFs) and FDA interactions. Required: Familiarity with advanced manufacturing technologies and regulatory pathways for novel platforms. Required: Strong understanding of GMP, ISO 9001, and quality systems. Required: Excellent communication, leadership, and project management skills. Preferred Experience:
Experience with oligonucleotide therapeutics Prior involvement with FDA Emerging Technologies Program or similar regulatory innovation initiatives. Knowledge of regulatory requirements for supporting third-party therapeutic developers.
Education
Advanced degree in life sciences, chemistry, or related field (PhD, PharmD, MS preferred).
#J-18808-Ljbffr
Associate Director/Director, CMC Regulatory Affairs will lead and execute regulatory activities for the ECO Synthesis platform and associated manufacturing activities. The role advances engagement with the FDA Emerging Technologies Program, supports pursuit of FDA Advanced Manufacturing Technology Designation, and prepares for GMP manufacturing and regulatory submissions including DMFs and IND support. The position also drives partner collaboration by supplying information and co-developing Module 3 CMC information for partner submissions. Responsibilities
Regulatory Strategy & Leadership
Develop and implement CMC regulatory strategies for the ECO Synthesis platform and GMP siRNA manufacturing. Lead interactions with regulatory agencies, including ongoing discussions with the FDA Emerging Technologies Team. Drive efforts toward achieving FDA Advanced Manufacturing Technology Designation.
Documentation & Submissions
Prepare and manage CMC sections of regulatory submissions including INDs, DMFs, and amendments. Support therapeutic developer customers by providing high-quality documentation for Module 3 of their INDs. Ensure alignment of regulatory documentation with ISO 9001 and future GMP standards.
Cross-functional Collaboration
Partner with Process Development, Quality, Manufacturing, and Business Development teams to ensure regulatory compliance and readiness. Provide regulatory guidance during the design and construction of the GMP manufacturing facility.
Compliance & Quality
Ensure regulatory compliance with evolving FDA and global regulatory expectations for advanced manufacturing technologies. Maintain awareness of regulatory trends and proactively assess their impact on company strategy.
Qualifications
Required: Advanced degree in life sciences, chemistry, or related field (PhD, PharmD, MS preferred). Required: 8+ years of experience in CMC regulatory affairs within the biotechnology or pharmaceutical industry. Required: Proven experience with regulatory submissions (INDs, DMFs) and FDA interactions. Required: Familiarity with advanced manufacturing technologies and regulatory pathways for novel platforms. Required: Strong understanding of GMP, ISO 9001, and quality systems. Required: Excellent communication, leadership, and project management skills. Preferred Experience:
Experience with oligonucleotide therapeutics Prior involvement with FDA Emerging Technologies Program or similar regulatory innovation initiatives. Knowledge of regulatory requirements for supporting third-party therapeutic developers.
Education
Advanced degree in life sciences, chemistry, or related field (PhD, PharmD, MS preferred).
#J-18808-Ljbffr