Job Details

Overview

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

Job Overview

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.

Responsibilities

• Manage and Develop Talent
• May train/mentor junior staff
• Phases I-IV Research & Development Activities
• 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
• Represent GRA on project team meetings
• Lead and coordinate project team members in developing strategy for applicable documents/activities
• Plan, coordinate, authors, 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 and contribute to content as needed
• Advise team members of major regulatory issues and provide possible solutions and mitigation strategies
• 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 regional health authority meetings and liaison with local Health Authority
• Document owner of briefing book documentation to Health Authorities
• Assist with development of the global regulatory functional plan and support successful submission and target labeling
• Accountable for developing and maintaining the development core data sheet (DCDS) if required
• Ensure compliance with global regulatory requirements and internal policies; coordinate global regulatory compliance activities
• 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) planning and execution of global regulatory activities and submissions
• May be responsible for creating and reviewing SOPs and regulatory department operating procedures

Qualifications

• 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/guidances specific to clinical research and general product development in the pharmaceutical industry
• Experience reviewing nonclinical, clinical and CMC documentation and contribute to content as needed
• Ability to analyze data, identify issues, and determine actions
• Proven success/major involvement in NDA/MAA/CTD submissions and approvals
• Strong negotiation skills and ability to defend positions
• Development and preparation of regulatory strategies and the ability to contribute to strategy documents
• Ability to learn new therapeutic areas when necessary
• Prior experience with post-marketing/brand optimization strategies and commercial awareness
• Experience interacting with FDA and ex-US Health Authorities
• Experience leading teams and providing leadership in Health Authority negotiations and meetings
• Ability to make complex decisions and defend difficult positions
• Comfortable presenting to all levels of the organization including Senior Management
• High degree of organizational awareness and understanding of interdependencies

Education and Experience

• Bachelor's degree in a related field required
• 8–12 years with Master's in a relevant experience in biotech or pharmaceutical industry with minimum of 8 years focused in regulatory affairs
• Master's degree required (preferably in a scientific discipline)

Compensation and Benefits

The base salary range for this role is $187,520 to $234,400. 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.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Compliance and Equal Opportunity

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer. Qualified applicants will receive 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; domestic violence victim status; atypical cellular or blood trait; genetic information or any other characteristic protected by law.

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, 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.