Associate Director, Regulatory Affairs

Sumitomo Pharma Co., is a global pharmaceutical company based in Japan with operations in the U.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 LinkedIn.
We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Associate Director Regulatory Affairs. The Associate 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. Manage and Develop Talent
~ 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), leads regulatory activities for assigned project(s) in line with the global registration strategy of the product
Competently represents GRA on project team meetings
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
Assesses and communicates regulatory requirements ensuring activities are in compliance with applicable regulations and guidelines
Leads documentation of regulatory authority interactions including decisions and outcomes

Provides updates at the Global Regulatory Team meetings and project teams as needed
Collaborates effectively with regulatory operations leader (ROL)
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 major regulatory issues and provides possible solutions and leads the mitigation strategy
Leads and coordinates local project team members in developing strategy for applicable documents/activities
Ensures the quality and content of all submissions to Health Authorities
Leads 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 as applicable 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
Leads Global Regulatory Team (GRT), oversees planning and execution of global regulatory activities and submissions
May be responsible for creating and reviewing SOPs and regulatory department operating procedures.
Unquestionable ethics, professional integrity, and personal values consistent with the SMPA values
Experience contributing to electronic regulatory submissions and working with regulatory templates
Advanced understanding of medical terminology, and FDA and ICH regulations/guidance 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
Development and preparation of successful regulatory strategies and the ability to contribute to the development and writing of a regulatory strategy document
Prior history with post-marketing/brand optimization strategies and commercial awareness
Comfortable presenting to all levels of the organization including Senior Management.
Bachelors degree in a related field required.
Masters degree required (preferably in a scientific discipline)
Approximately 7 years of prior biopharmaceutical or pharmaceutical industry experience; Ideally with a minimum of 4 years focused in regulatory affairs
Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Confidential Data
that an employee encounters is considered confidential.
Compliance
Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the best industry practices and the highest ethical standards.
Requires ability to use a personal computer for extended periods of time.
marital, domestic partnership or civil union status; disability; veteran or military status or liability for military status; domestic violence victim status; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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