Sumitomo Pharma
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S., Canada, and Europe, focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies.
Job Overview
We are 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, primarily functioning as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects. Job Duties and Responsibilities Manage and Develop Talent: May train/mentor junior staff Phases I-IV Research & Development Activities: Manage regional regulatory activities, lead regulatory activities for assigned projects, represent GRA on project team meetings, and coordinate project team members in developing strategy for applicable documents/activities. Plan, coordinate, author, and prepare regulatory submissions, working closely with Regulatory Operations in electronic submission. Assess and communicate regulatory requirements, ensuring activities comply with applicable regulations and guidelines. Lead documentation of regulatory authority interactions, including decisions and outcomes. Provide updates at Global Regulatory Team meetings and project teams as needed. Collaborate effectively with regulatory operations leader (ROL) and maintain professional working relationships with colleagues. Review nonclinical, clinical, and CMC documentation, contributing to content as needed. Advise team members on major regulatory issues, providing possible solutions and leading mitigation strategy. Key Core Competencies Strong verbal and written communication skills, interpersonal skills, listening skills, and organizational skills. Unquestionable ethics, professional integrity, and personal values consistent with SMPA values. Demonstrated ability to adapt to changing priorities and work effectively in a matrix organization. Sense of urgency and perseverance to achieve results. Experience contributing to electronic regulatory submissions and working with regulatory templates. Advanced understanding of medical terminology, FDA, and ICH regulations/guidances specific to clinical research and general product development in the pharmaceutical industry. Education and Experience Bachelor’s degree in a related field required, with 8-12 years of experience in the biotech or pharmaceutical industry, including a minimum of 8 years focused on regulatory affairs. Master’s degree preferred, preferably in a scientific discipline. The base salary range for this role is $187,520 to $234,400, with a total rewards package including 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. Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer, providing consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital, domestic partnership or civil union status, sex, gender, affectional or sexual orientation, disability, veteran or military status, or liability for military status.
#J-18808-Ljbffr
Director Regulatory Affairs . The Director is part of the Global Regulatory Affairs (GRA) team based in the US, primarily functioning as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects. Job Duties and Responsibilities Manage and Develop Talent: May train/mentor junior staff Phases I-IV Research & Development Activities: Manage regional regulatory activities, lead regulatory activities for assigned projects, represent GRA on project team meetings, and coordinate project team members in developing strategy for applicable documents/activities. Plan, coordinate, author, and prepare regulatory submissions, working closely with Regulatory Operations in electronic submission. Assess and communicate regulatory requirements, ensuring activities comply with applicable regulations and guidelines. Lead documentation of regulatory authority interactions, including decisions and outcomes. Provide updates at Global Regulatory Team meetings and project teams as needed. Collaborate effectively with regulatory operations leader (ROL) and maintain professional working relationships with colleagues. Review nonclinical, clinical, and CMC documentation, contributing to content as needed. Advise team members on major regulatory issues, providing possible solutions and leading mitigation strategy. Key Core Competencies Strong verbal and written communication skills, interpersonal skills, listening skills, and organizational skills. Unquestionable ethics, professional integrity, and personal values consistent with SMPA values. Demonstrated ability to adapt to changing priorities and work effectively in a matrix organization. Sense of urgency and perseverance to achieve results. Experience contributing to electronic regulatory submissions and working with regulatory templates. Advanced understanding of medical terminology, FDA, and ICH regulations/guidances specific to clinical research and general product development in the pharmaceutical industry. Education and Experience Bachelor’s degree in a related field required, with 8-12 years of experience in the biotech or pharmaceutical industry, including a minimum of 8 years focused on regulatory affairs. Master’s degree preferred, preferably in a scientific discipline. The base salary range for this role is $187,520 to $234,400, with a total rewards package including 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. Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer, providing consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital, domestic partnership or civil union status, sex, gender, affectional or sexual orientation, disability, veteran or military status, or liability for military status.
#J-18808-Ljbffr