Overview

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.). The company focuses on oncology, urology, women's health, rare diseases, cell & gene therapies and CNS with a diverse pipeline. For more information on SMPA, visit our website or follow us on LinkedIn.

Job Overview

We are 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. The role functions as a regional regulatory leader (RRL) and/or Global Regulatory Leader (GRL) for assigned products. Responsibilities include preparation, coordination and monitoring of routine US and/or global regulatory submissions and responses to health authority information requests. The role may represent GRA in project 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.

Job Duties and Responsibilities

• As a Regional Regulatory Lead, manage regional (United States, European and/or ROW) regulatory activities as part of a Global Regulatory Team (GRT)
• As part of the Global Regulatory Team (GRT), lead regulatory activities for assigned project(s) in line with the global registration strategy
• Support the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of regulatory strategy and interactions with health authorities
• Support and/or lead documentation of regulatory authority interactions including decisions and outcomes
• Lead and coordinate project team members in developing strategy for applicable documents/activities
• Plan, coordinate, author, and prepare regulatory submissions and work with Regulatory Operations in the electronic submission
• Ensure compliance with global regulatory requirements and adherence to internal policies and processes; coordinate global regulatory compliance activities
• Provide updates to the Global Regulatory Team, project teams, and governance boards as needed
• Maintain professional working relationships with colleagues to foster collaboration and idea sharing
• Review nonclinical, clinical and CMC documentation and contribute to content as needed
• Advise team members of potential regulatory issues and provide solutions and mitigation strategies
• Ensure the quality and content of all submissions to Health Authorities
• Contribute to regional health authority meetings and briefing book documentation to Health Authorities
• Assist with development of the global regulatory functional plan through research and interpretation of regulatory guidance documents to support successful submissions and target product labeling
• Responsible for creating and reviewing SOPs and regulatory department operating procedures as needed

Key Core Competencies

• Strong verbal and written communication, interpersonal, listening, and organizational skills
• Unquestionable ethics and professional integrity aligned with SMPA values
• Ability to work in a diverse environment
• Ability to adapt to changing priorities and work effectively in a matrix organization
• Ability to facilitate appropriate team decisions
• Sense of urgency and perseverance to achieve results
• Understanding of medical terminology and FDA/ICH regulations and guidance related to clinical research and product development
• Experience reviewing nonclinical, clinical and CMC documentation and contributing to content as needed
• Ability to analyze data from different sources to determine courses of action or solutions
• Contribution to development and writing of regulatory strategies
• Ability to make complex decisions and defend difficult positions
• Comfortable presenting to all levels of the organization including Senior Management

Education and Experience

• Bachelor’s degree in a related field required, preferably in a scientific discipline
• At least 7 years of experience in biopharmaceutical or pharmaceutical industry; ideally with a minimum of 4 years focused in regulatory affairs
• Oncology product development experience preferred
• Experience contributing to electronic regulatory submissions and working with regulatory templates
• Understanding of EU Clinical Trial Regulation and ROW country regulatory requirements related to clinical trials

Compensation and Benefits

The base salary range for this role is $156,000 to $195,000. Base salary is part of our total rewards package, which includes merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances, and leaves in line with your work state. Our time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a year-end shutdown, and 80 hours of paid sick time upon hire and each year thereafter. Total compensation will depend on candidate experience, skills, education and other factors permitted by law.

Compliance and Accessibility

Disclaimer: The statements describe the general nature and level of work. All personnel may be required to perform duties outside of their normal responsibilities from time to time.

Confidential Data: All information encountered is considered confidential. Compliance: Maintain compliance with applicable regulatory, legal and operational rules and procedures.

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer. Qualified applicants will receive consideration without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital status, sex, gender, disability, veteran status, or any other protected characteristic.

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with US operations. For more information visit our website or follow on LinkedIn. If you need assistance with accessibility or completing the application process, contact SMPA at reasonableaccomodations@us.sumitomo-pharma.com (for accommodation requests only).

Our Mission: To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare worldwide.

Our Vision: For Longer and Healthier Lives, we unlock the future with cutting edge technology and ideas.