Associate Director, Regulatory Affairs

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 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 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 (INDs, NDAs).
• In alignment with Program Management, maintains project timelines and provides updates to senior management.
• On a regular basis, meets with authors / reviewers monitor status of document creation and finalization as per project / content plan.
• In collaboration with GRL and CMC RA lead, provides updates on dossier compilation to IND / NDA team

Liaison to Reg Ops team / oversight of Reg Ops activities

• Overseeing the tracking, compiling, publishing, quality checking, dispatching and archiving of Health Authority submissions.  Managing the activities of external staff contracted to pre-publish, publish and dispatch health authority submissions and archive correspondence.
• Represents RA Oncology on project teams for matters relating to electronic (and paper) submissions as assigned.
• Advises and/or trains project teams on new requirements, along with proposals for implementation, through robust understanding of HA standards and procedures for regulatory submissions.
• 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.
• Other duties as assigned.

Key Core Competencies

• Requires a detail-oriented self-starter with excellent organizational, planning, and follow-up skills, as well as teamwork, and interpersonal skills.
• Effective communication and presentation skills. Experience in leading local system or process improvement projects. 
• Foundational strategic thinking and problem-solving skills.
• Ability to meet tight competing deadlines, juggle multiple priorities and multi-task.
• Working across cult