🚀 Director, Regulatory Affairs

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 team based in the US. The role 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.

Job Duties and 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 the GRA on project team meetings
• 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 electronic submission
• Assess and communicate regulatory requirements ensuring activities are compliant 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)
• 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 liaise with local Health Authorities
• Document owner of briefing book documentation to Health Authorities
• Assist with development of the global regulatory functional plan and support successful submissions and target product labeling
• Accountable for developing and maintaining the development core data sheet (DCDS) if required, in conjunction with the GRL
• Ensure compliance with global regulatory requirements and internal policies and coordinate regulatory compliance activities globally
• 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), oversee planning and execution of global regulatory activities and submissions
• May be responsible for creating and reviewing SOPs and regulatory department operating procedures

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
• 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
• 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 product development in the pharmaceutical industry
• Experience reviewing nonclinical, clinical and CMC documentation and contribute to content as needed
• Ability to analyze data from multiple sources to inform action or solution
• Proven involvement in NDA/MAA/CTD submissions and approvals
• Negotiation skills with composure
• Development and preparation of regulatory strategies and ability to contribute to strategic documents
• Ability to learn new therapeutic areas when necessary
• Experience with post-marketing/brand optimization strategies and commercial awareness
• Experience interacting with the FDA and ex-US Health Authorities
• Experience in 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 organizational awareness and ability to understand interdependencies

Education and Experience

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

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 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 describe the general nature and level of work performed by people assigned to this classification. They are not to be construed as an exhaustive list of responsibilities. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Compliance: Achieve and maintain compliance with all applicable regulatory, legal and operational rules and procedures, ensuring plans and activities for SMPA and affiliates are carried out with high ethical standards.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment. Equal Employment Opportunity: SMPA is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital status, sex, gender, sexual orientation, disability, veteran or military status, or other protected characteristics.

Sumitomo Pharma America is a global pharmaceutical company with operations described above. For more information, visit our website or follow us on LinkedIn.