Associate Director, Regulatory Affairs; Oncology

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.

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We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Associate Director, Regulatory Affairs (Oncology). The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will primarily function as a regional regulatory leader (RRL) and/or Global Regulatory Leader (GRL) for assigned products. This position is responsible for the preparation, coordination and monitoring of routine US and/or global regulatory submissions and responses to health authority (HA) information requests.

In addition, this position may represent GRA in project related meetings, develop regulatory strategy and provide regulatory input as appropriate.

This position works with a moderate level of independence and autonomy and requires some coaching and mentoring.

• As a Regional Regulatory Lead, manage regional (United States, European and/or ROW) regulatory activities as part of a Global Regulatory Team (GRT)
• As a part of the Global Regulatory Team (GRT), leads regulatory activities for assigned project(s) in line with the global registration strategy of the product
• Supports the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of regulatory strategy, and interactions with HAs
• Supports and/or leads documentation of regulatory authority interactions including decisions and outcomes
• Leads and coordinates project team members in developing strategy for applicable documents/ activities.
• Plans, coordinates, authors, and prepares regulatory submissions and works closely with Regulatory Operations in the electronic submission
• Ensure compliance with global regulatory requirements and adherence to regulatory internal policies and processes and coordinate regulatory compliance activities at a global level
• Provide updates to the Global Regulatory Team, project teams, and governance boards as needed
• Maintains professional working relationships with colleagues, fostering collaboration, and idea sharing
• Reviews nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contributes to content as needed
• Advises team members of potential regulatory issues and provides possible solutions and mitigation strategy
• Ensures the quality and content of all submissions to Health Authorities
• Contributes to regional health authority meetings, and 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
• Responsible for creating and reviewing SOPs and regulatory department operating procedures, as needed.

• 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
• 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 needed
• Understands issues, problems and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution
• Contribution to the development and preparation of successful regulatory strategies and the ability to contribute to the development and writing of a regulatory strategy document
• Ability to make complex decisions and willingness to defend difficult positions.
• Comfortable presenting to all levels of the organization including Senior Management.

• Bachelor’s degree in a related field required, preferably in a scientific discipline.
• At least 7 years of…