Nature and Scope Regulatory submissions/operations professional with experience in complete pharmaceutical development life-cycle management. The focus of this position will be to ensure publishing compliance to FDA, EU and Health Canada regulations. Focus on delivery with excellence while maintaining quality and compliance. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Obtain regulatory documents and initiate eCTD compilation using templates, publishing tools and publishing software. Prepare high-quality regulatory submissions for multiple programs/products in development (e.g. IND, NDA, ANDA, and VMF) with a focus on eCTD. This includes managing and maintaining a regulatory submissions schedule for annual reports, supplements, FDA correspondences, responses, and other submissions. Review and dispatch of regulatory submissions to the FDA and global Health Authorities within required timeframes. Ensure completion of high-quality submissions in eCTD format in compliance with applicable regulations, guidance, and Regulatory Submissions standards. Maintain proficiency and expertise with the tools and processes associated with electronic regulatory submissions; Responsible for archival and indexing of regulatory files. Prepare and maintain Regulatory SOPs, Policies and Procedures regarding electronic submission and requirements. Maintain Regulatory department metrics and databases. Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Bachelor's Degree in scientific field and/or computer science. Minimum 2 Years pharmaceutical industry experience. Minimum 1 Year within Regulatory Affairs. Knowledge of FDA regulations and cGMP requirements. Must be detail oriented, and able to perform work independently with moderate supervision Strong organizational, interpersonal and communication skills (oral and written). Microsoft Office, electronic document management systems, electronic submissions software, eCTD submission format and electronic validation requirements. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. American Regent Inc. endeavors to make accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email . We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.