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Senior Manager, Regulatory Operations
1 month ago
Sumitomo Pharma Senior Manager, Regulatory Operations Des Moines, Iowa Apply Now 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. Job Overview We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Senior Manager, Regulatory Operations. For assigned projects, the Senior Manager of Regulatory Operations is responsible for managing all Regulatory Affairs activities involving compilation, publishing, distribution, and archiving of health authority submissions. Job Duties and Responsibilities Overseeing the external Submission Managers with defining submission outlines, content, format, and quality requirements for electronic submissions, with input from Regulatory Affairs staff as needed. Manages the external Submission Managers to ensure the accurate and timely management of tracking, compiling, publishing, quality checking, dispatching, and archiving of Health Authority submissions. Facilitates submission preparation via completion of forms and creation of cover letters. Represents Regulatory Operations on project teams for matters relating to electronic (and paper) submissions. Overseeing the external Submission Managers to ensure accurate printing, distributing, and archiving all incoming and outgoing communications with FDA and international counterpart agencies. Leads in the implementation, validation, and operation of eCTD and electronic document management systems and other publishing and submissions technology projects. Leads the development, refinement, and implementation of internal processes, procedures, work instructions, and training programs for submission production and operational support activities. Understands evolving Health Authority (HA) standards and procedures for regulatory submissions and guides project teams on new requirements. Coordinating and consulting with other departments on the content, review, and assembly of regulatory documentation. Assisting in the creation of regulatory project plans and timelines for multiple projects. Leads the training of appropriate R&D staff in the application of various standards and technologies. Key Core Competencies Requires a detail-oriented self-starter with excellent organizational, planning, and follow-up skills, as well as communication, teamwork, and interpersonal skills. Ability to meet tight competing deadlines, juggle multiple priorities and multi-task. Extensive knowledge of regulatory submission publishing standards and procedures, including computer word processing, electronic document management systems, and regulatory publishing software. Education and Experience High School (Bachelor’s degree preferred). Minimum 8 years (w/o Master’s) or 6 – 8 years (with Master’s) of relevant experience in biotech or pharmaceutical industry. 7+ years’ experience in a fast-paced, high-volume document production environment. Compensation The base salary range for this role is $126,600 to $155,000. Confidential Data : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. Compliance : Achieve and maintain compliance with all applicable regulatory, legal, and operational rules and procedures. Mental/Physical Requirements : Fast-paced environment handling multiple demands. Requires a high level of initiative and independence. Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) and Affirmative Action employer. #J-18808-Ljbffr
