Sumitomo Pharma America, Inc is hiring: Director, Regulatory Advertising & Promo

Position: Director of Regulatory Advertising & Promotion

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.) that focuses 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.
Responsibilities

As a regulatory reviewer for assigned products, you will provide strategic, expert guidance on the advertising and promotion of these products. Your work will involve reviewing and approving promotional materials to ensure compliance with FDA regulations, PhRMA guidelines, and other relevant codes of practice. You will collaborate closely with internal stakeholders such as Marketing, Legal, Compliance, and Medical Affairs, as well as external vendors and consultants. Key duties include:
Review and approve marketing materials to meet regulatory requirements and company principles;
Align with regulatory colleagues on strategies to optimize the commercial success of products for clinical trials, labeling, and promotion;
Maintain relationships with the Office of Prescription Drug Promotion (OPDP) at FDA and serve as the internal expert on FDA regulations, guidance, and enforcement trends;
Develop and review SOPs and department operating procedures;
Provide oversight of promotional material review and ensure on‑time submission to regulatory agencies;
Mentor or supervise junior staff and/or external consultants as needed.
Qualifications

8–12 years of experience in the biotech or pharmaceutical industry, with at least 8 years focused on regulatory advertising & promotion;
Advanced degree preferably in a scientific discipline (advanced degree preferred but not mandatory);
Excellent verbal and written communication, interpersonal and listening skills; strong organizational skills and the ability to influence across the organization.
Core Competencies

Unquestionable ethics, professional integrity, and personal values consistent with the company mission; ability to work in a diverse environment;
Ability to prioritize tasks and work across locations and time zones; adaptability to changing priorities in a matrix organization;
Track record of leading promotional copy review and approval teams; experience with OPDP staff and management;
Sense of urgency and perseverance to achieve results; effective negotiation skills while maintaining composure;
Capacity to learn new therapeutic areas when necessary; ability to make complex decisions and defend difficult positions;
Comfortable presenting to all levels of the organization including senior management.
Compensation and Benefits

Base salary range: $187,520 to $234,400. Salary is part of the total rewards package, which also includes merit‑based salary increases, a short incentive plan, eligibility for the 401(k) plan, medical, dental, vision, life and disability insurance, and leave in accordance with state laws.
Unlimited paid time off;
11 paid holidays and additional time off for the close‑down period in December;
80 hours of paid sick time upon hire and each year thereafter.
Disclaimer

The above statements describe the general nature and level of work performed by people assigned to this classification. They are not an exhaustive list of all responsibilities, duties, and skills required. All personnel may be required to perform duties outside their normal responsibilities from time to time.
Confidentiality and Compliance

All information encountered by an employee—written, verbal, or electronic—is considered confidential. Employees must achieve and maintain compliance with all regulatory, legal, and operational rules and procedures, ensuring the highest ethical standards.
Mental/Physical Requirements

Fast‑paced environment handling multiple demands; ability to exercise appropriate judgment, independence, and strong communication skills; requires personal computing for extended periods.
Equal Employment Opportunity

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

#J-18808-Ljbffr