Senior Manager, Regulatory Operations

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, and a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.

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.

The Senior Manager will oversee the activities of external publishing staff contracted to publish and dispatch health authority submissions.

Job Duties and Responsibilities

• Defines submission outlines, content, format, and quality requirements for electronic submissions.
• Manages the tracking, compiling, publishing, quality checking, dispatching and archiving of Health Authority submissions.  As needed, prepares and dispatches OPDP submissions. Manages the activities of external publishing staff contracted to publish and dispatch health authority submissions.
• Represents Regulatory Operations on project teams for matters relating to electronic (and paper) submissions.
• Distributing, and archiving all incoming and outgoing communications with FDA and international counterpart agencies.
• Understands evolving Health Authority (HA) standards and procedures for regulatory submissions. Guides and trains project teams on new requirements, along with proposals for implementation
• Coordinating and consulting with other departments on the content, review, and assembly of regulatory documentation.  Ensure consistency, completeness, and adherence to standards for all regulatory submission documents.
• 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.
• Manages the planning, tracking, compiling, quality checking and submission of required FDA Submissions (e.g. Establishment Registrations, Drug Product Listings).
• Manages process to ensure that the clinical trial registry is updated to meet the regulatory requirements (e.g. entire management of the registry including timeline and liaison to regulators if needed)

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.
• Expert knowledge of regulatory submission publishing standards and procedures, including computer word processing, electronic document management systems, and regulatory publishing software. 
• Robust understanding of FDA and other health agency regulations and guidances governing submission content and format.

Education and Experience

• Bachelor’s degree preferred or equivalent experience
• Minimum 8 – 12 (w/o Master’s) or 6 – 8 years (with Master’s) years of relevant experience in biotech or pharmaceutical industry
• Experience in a fast-paced, high-volume document production environment (e.g., documentation, publications, electronic publishing) or clinical environment, preferably in the biotechnology/ pharmaceutical industry or another health care industry.