Director, Regulatory Affairs Oncology

Overview

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner.

For more information on SMPA, visit our website  or follow us on Linked In.

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Director Regulatory Affairs. The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects. This position is expected to lead the development and implementation of regulatory strategy from proof of concept, development, registration, and post-approval for projects within the portfolio of the company.

This position may train/mentor junior staff.

This position works with a high level of autonomy and requires limited coaching and mentoring.

Job Duties and Responsibilities

• May train/mentor junior staff.
• As a Regional Regulatory Lead, manage regional (United States and/or European) regulatory activities as part of a Global Regulatory Team (GRT).
• As a part of the Global Regulatory Team (GRT), lead regulatory activities for assigned project(s) in line with the global registration strategy of the product.
• Competently represents GRA on project team meetings.
• Lead and coordinate project team members in developing strategy for applicable documents/ activities.
• Plan, coordinate, author, and prepare regulatory submissions and work closely with Regulatory Operations in the electronic submission.
• Assess and communicate regulatory requirements ensuring activities are in compliance with applicable regulations and guidelines.
• Lead documentation of regulatory authority interactions including decisions and outcomes.
• Provide updates at the Global Regulatory Team meetings and project teams as needed.
• Collaborate effectively with regulatory operations leader (ROL).
• Maintain professional working relationship with colleagues, fostering collaboration, and idea sharing.
• Review nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contribute to content as needed.
• Advise team members of major regulatory issues and provide possible solutions and lead the mitigation strategy.
• Lead and coordinate local project team members in developing strategy for applicable documents/activities.
• Ensure the quality and content of all submissions to Health Authorities.
• Lead the regional health authority meetings, liaison with local Health Authority.
• Document owner of briefing book documentation to Health Authorities.
• Assist with development of the global regulatory functional plan through research, review and interpretation of related product approvals, current regulatory guidance documents and recent public Advisory Committee proceedings to support the successful submission and achievement of target product labeling.
• Accountable in conjunction with the GRL for developing and maintaining the development core data sheet (DCDS) if required.
• Ensure compliance with global regulatory requirements and adherence to regulatory internal policies and processes and coordinate regulatory compliance activities at a global level.
• Provide strategic review of dossier summaries, expert statements, and development management plans.
• Provide updates to the GRT, project teams, and governance boards as needed.
• Lead Global Regulatory Team (GRT), oversee planning and execution of global regulatory activities and submissions.
• May be responsible for creating and reviewing SOPs and regulatory department operating procedures.

• Strong verbal and written communication skills; interpersonal skills; listening skills; and organizational skills required.
• Unquestionable ethics, professional integrity, and personal values consistent with the SMPA values.
• Ability to work in a diverse environment.
• Demonstrated ability to adapt to changing priorities and work effectively in a matrix organization.
• Demonstrated ability to facilitate appropriate team decisions.
• Sense of urgency and perseverance to achieve results.
• Experience contributing to electronic regulatory submissions and working with regulatory templates.
• Advanced understanding of medical terminology, and FDA and ICH regulations/guidance documents specific to clinical research and general product development in the pharmaceutical industry.
• Experience reviewing nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contribute to content as…