What are the responsibilities and job description for the Associate Director, Regulatory Affairs position at Idaho State Job Bank?
Associate Director, Regulatory Affairs at Sumitomo Pharma in Boise, Idaho, United States Job Description Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website (or follow us on LinkedIn (. Job Overview We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Associate Director Regulatory Affairs. The Associate Director Regulatory Affairs is a member of the Regulatory Project team leading maintenance submissions to the IND / CTA / NDA, developing and maintaining project and content plans for complex submissions (IND / NDA) and overseeing Regulatory Operations activities including publishing, submitting and archiving of regulatory submissions and correspondence. Job Duties and Responsibilities Lead maintenance submissions to the IND / CTA / NDA Leads preparation, coordination, authoring and monitoring of CTA / IND / NDA maintenance submissions (e.g., annual reports, investigator brochures, IND amendments) Attend project team meetings to provide input into regulatory requirements and company standards for IND / CTA / NDA maintenance submissions. Defines submission outlines, content, format, and quality requirements for electronic submissions, with input from Regulatory Affairs staff as needed to ensure submission readiness. Coordinates and consults with other departments on the content, review, and assembly of regulatory documentation. Facilitates submission preparation via completion of forms and creation of cover letters. Submissions Project Management Creates and maintains regulatory content and project plans and timelines for major submission projects To view full details and how to apply, please login or create a Job Seeker account
