NWRPros
Temporary Senior Specialist Regulatory Affairs Operations
NWRPros, Brisbane, California, United States, 94005
Overview
Our clienta clinical-stage genomic medicine companyrecently achieved a major regulatory milestone for its lead gene therapy program targeting a rare lysosomal storage disorder. Following positive clinical trial data, the FDA has aligned with the company on an Accelerated Approval pathway, using an intermediate clinical endpoint as the basis for submission. A Biologics License Application (BLA) is expected in 2026. Recent regulatory meetings have also clarified the Chemistry, Manufacturing, and Controls. Job Summary
Our Client is seeking a temporary Regulatory Affairs Operations Senior Specialist to join our team, ensuring the Company meets US and EU regulatory submission requirements. The successful candidate will be responsible for coordination, preparation, tracking and filing of document packages for regulatory submission from all areas of research and development. This is a temporary position. Essential Functions
Preparation, coordination, compilation, formatting, and filing of global regulatory submissions, including INDs, CTAs, BLAs, Drug Master Files, DSURs, Meeting Materials and IND amendments providing for changes in the clinical program and manufacture of the product. Understand electronic common technical document (eCTD) submission requirements in both the US and EU and interface closely with publishing vendor(s) to process, validate and approve eCTD submissions Maintain/archive all regulatory submissions and correspondence for company sponsored projects, and all company related sections for partner sponsored projects. Responsible for business administration of Regulatory systems (SharePoint, InSight Publisher/Viewer and Veeva Vault RIM), including (but not limited to) user management, training, issue escalation and resolution and working with IT and third-party providers. Maintain up-to-date knowledge of global standards and procedures for regulatory submissions and publishing standards, including eCTD and CTA; analyze new guidance documents and requirements related to electronic submissions, and recommend courses of action. Prepare special reports and assemble documentation to support department activities as needed Identify process improvements and automation opportunities to increase operational efficiency while ensuring submission integrity. Ensure that issues are identified at an early date and actively contribute to issue resolution before filing dates are impacted. Education, Experience and Skills Requirements
Bachelor's degree, preferably in a scientific/technical discipline, or equivalent work experience 3+ years of regulatory operations experience Excellent document formatting and publishing skills using MS Word (particular emphasis on document formatting), Adobe Acrobat, PowerPoint and Excel Experience in eCTD filings Experience in European Regulatory submission policies and practices Excellent and hands-on experience in technologies such as SharePoint, eCTD Publishing Tools (InSight Publisher/Viewer), Veeva Vault RIM, and off-the shelf and plug-in software such as DXC Toolbox that supports Regulatory publishing Detail-oriented with a capacity to deliver accurate results. Able to execute operational processes and quality process checks that ensure regulatory compliance. Flexibility to work effectively within an environment with quickly changing processes, priorities, and deadlines and have strong problem-solving skills regarding streamlining non-routine problems in relation to department procedures and processes. Ready to embrace a culture of flexibility and innovation, with a very high degree of urgency and commitment to translating ground-breaking science into genomic therapies that transform patients' lives Pay Range
The anticipated salary range is for candidates who will work in the San Francisco Bay Area work locations. The final salary offered to a successful candidate will be dependent on several factors that may include, but are not limited to, the type and length of experience with the job, type and length of experience within the industry, education, etc. This salary range may not apply to remote positions that work in other states. #J-18808-Ljbffr
Our clienta clinical-stage genomic medicine companyrecently achieved a major regulatory milestone for its lead gene therapy program targeting a rare lysosomal storage disorder. Following positive clinical trial data, the FDA has aligned with the company on an Accelerated Approval pathway, using an intermediate clinical endpoint as the basis for submission. A Biologics License Application (BLA) is expected in 2026. Recent regulatory meetings have also clarified the Chemistry, Manufacturing, and Controls. Job Summary
Our Client is seeking a temporary Regulatory Affairs Operations Senior Specialist to join our team, ensuring the Company meets US and EU regulatory submission requirements. The successful candidate will be responsible for coordination, preparation, tracking and filing of document packages for regulatory submission from all areas of research and development. This is a temporary position. Essential Functions
Preparation, coordination, compilation, formatting, and filing of global regulatory submissions, including INDs, CTAs, BLAs, Drug Master Files, DSURs, Meeting Materials and IND amendments providing for changes in the clinical program and manufacture of the product. Understand electronic common technical document (eCTD) submission requirements in both the US and EU and interface closely with publishing vendor(s) to process, validate and approve eCTD submissions Maintain/archive all regulatory submissions and correspondence for company sponsored projects, and all company related sections for partner sponsored projects. Responsible for business administration of Regulatory systems (SharePoint, InSight Publisher/Viewer and Veeva Vault RIM), including (but not limited to) user management, training, issue escalation and resolution and working with IT and third-party providers. Maintain up-to-date knowledge of global standards and procedures for regulatory submissions and publishing standards, including eCTD and CTA; analyze new guidance documents and requirements related to electronic submissions, and recommend courses of action. Prepare special reports and assemble documentation to support department activities as needed Identify process improvements and automation opportunities to increase operational efficiency while ensuring submission integrity. Ensure that issues are identified at an early date and actively contribute to issue resolution before filing dates are impacted. Education, Experience and Skills Requirements
Bachelor's degree, preferably in a scientific/technical discipline, or equivalent work experience 3+ years of regulatory operations experience Excellent document formatting and publishing skills using MS Word (particular emphasis on document formatting), Adobe Acrobat, PowerPoint and Excel Experience in eCTD filings Experience in European Regulatory submission policies and practices Excellent and hands-on experience in technologies such as SharePoint, eCTD Publishing Tools (InSight Publisher/Viewer), Veeva Vault RIM, and off-the shelf and plug-in software such as DXC Toolbox that supports Regulatory publishing Detail-oriented with a capacity to deliver accurate results. Able to execute operational processes and quality process checks that ensure regulatory compliance. Flexibility to work effectively within an environment with quickly changing processes, priorities, and deadlines and have strong problem-solving skills regarding streamlining non-routine problems in relation to department procedures and processes. Ready to embrace a culture of flexibility and innovation, with a very high degree of urgency and commitment to translating ground-breaking science into genomic therapies that transform patients' lives Pay Range
The anticipated salary range is for candidates who will work in the San Francisco Bay Area work locations. The final salary offered to a successful candidate will be dependent on several factors that may include, but are not limited to, the type and length of experience with the job, type and length of experience within the industry, education, etc. This salary range may not apply to remote positions that work in other states. #J-18808-Ljbffr