RA Director

The candidate selected for this role will work in the north suburb of Chicago, overseeing the Regulatory Affairs activities at SparX’s Mount Prospect biologics manufacturing facility. Responsibilities include: Develop and implement regulatory strategies for new and existing products throughout their lifecycle, including those related to CMC, clinical, and non-clinical issues. Compile, write, review, and approve regulatory submissions (i.e., pre-IND, IND, NDA, supplements, annual reports, IND safety reports, study protocols, and study reports), ensuring high quality and compliance with global regulatory guidelines while meeting aggressive timelines. Interact with health authorities in US and globally. Co-ordinate and consult with cross functional areas regarding the content, review, and assembly of regulatory documentation, ensuring consistency, completeness, and adherence to standards for regulatory submissions. Provide regulatory representation on project teams and provide clear and consistent regulatory recommendations and guidance based on sound regulatory strategy. Apply up-to-date knowledge of regulatory and quality compliance requirements and communicate changes in regulatory information to project teams and management. Problem-solve issues to preserve original timelines; track progress while being accountable for regulatory deliverables. Collaborate with multiple departments including Process Development, Manufacturing, Clinical Affairs, and Medical Affairs to develop and implement effective regulatory strategies that compliment business development. Assess scientific data against regulatory requirements for registration. Maintain good regulatory archive processes as well as effective communication with the team. Develop and maintain regulatory SOPs, processes, procedures, and templates. Comply with all Corporate policies, rules, and regulations as set out and communicated by the company pursuant to good business practice. Focus on organizational excellence; Coach and develop staff with skills in operational, technical, and regulatory leadership to make good, timely decisions and achieve impactful outcomes. Perform other related duties as assigned by management.