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Senior Manager, Regulatory Operations
1 month ago
Sumitomo Pharma Senior Manager, Regulatory Operations Jackson, Mississippi 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. Manages the external submission Managers to ensure the accurate and timely management of the 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 or developmental programs. Leads the training of appropriate R&D staff in the application of various standards and technologies including templates, document management practices, eCTD publishing, and other tools used within the group. Key Core Competencies Detail-oriented self-starter with excellent organizational, planning, and follow-up skills. Ability to meet tight competing deadlines, juggle multiple priorities and multi-task. Extensive knowledge of regulatory submission publishing standards and procedures. Thorough understanding of FDA and other health agency regulations governing submission content and format. Education and Experience High School (Bachelor’s degree preferred) with a minimum of 8 years (without Master’s) or 6 – 8 years (with Master’s) of relevant experience in the biotech or pharmaceutical industry. 7+ years’ experience in a fast-paced, high-volume document production environment, preferably in the biotechnology/pharmaceutical industry. Compensation The base salary range for this role is $126,600 to $155,000. Our total rewards package includes merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, and various insurances and paid time off policies. 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. Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital status, sex, gender, gender identity or expression, disability, veteran status, or any other characteristic protected by law. #J-18808-Ljbffr
