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Senior Manager, Regulatory Operations
3 months ago
Sumitomo Pharma Senior Manager, Regulatory Operations Baton Rouge, Louisiana 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 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.
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.
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 and guidance governing submission content and format.
Education and Experience
High School (Bachelor’s degree preferred). Minimum 8 years (without Master’s) or 6 – 8 years (with Master’s) of relevant experience in the biotech or pharmaceutical industry.
Salary and Benefits
The base salary range for this role is $126,600 to $155,000. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, and eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances.
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. Excellent written and oral communication skills required.
Equal Employment Opportunity : Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to any characteristic protected by law.
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