Sumitomo Pharma is hiring: Director, Regulatory Advertising & Promotion in Olymp

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 oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With marketed products in the U.S., Canada, and Europe and a diverse pipeline, 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.

Job Overview

We are seeking a dynamic, highly motivated, and experienced individual for the position of Director, Regulatory Advertising & Promotion. This role is part of the Global Regulatory Affairs (GRA) team based in the US and will primarily function as the Regulatory reviewer for assigned products. The position provides strategic, expert guidance on the advertising and promotion of assigned products, balancing regulatory requirements with business needs and objectives. It may train/mentor junior staff and/or oversee external consultants. This role works with a high level of autonomy and requires limited coaching and mentoring.

Job Duties and Responsibilities

• Advertising & Promotion Review Activities: Review and approve materials that comply with relevant external advertising and promotional regulations or codes of practice (e.g., FDA regulations, PhRMA guidelines) and are consistent with company guiding principles.
• Align with regulatory colleagues on strategies to optimize the commercial success of products for clinical trials, labeling, etc.
• Develop and maintain productive working relationships with colleagues and vendors contributing to development, review, and approval of promotional materials, e.g., Marketing and their Agencies, Legal, Compliance, and Medical Affairs.
• Provide oversight of promotional material review and ensure on-time and accurate submission of applicable materials to regulatory agencies.
• Establish a working relationship with the Office of Prescription Drug Promotion (OPDP) at FDA.
• Serve as internal regulatory expert on FDA regulations, guidance and enforcement trends governing the promotion of prescription therapies.
• May be responsible for creating and reviewing SOPs and department operating procedures.

Manage and Develop Talent

• May train/mentor junior staff and/or oversee external consultants.

Key Core Competencies

• Strong verbal and written communication skills; interpersonal skills; listening skills; and organizational skills with the ability to influence others, internally and externally, in a positive and effective manner.
• Unquestionable ethics, professional integrity, and personal values consistent with the SMPA values.
• Ability to work in a diverse environment.
• Ability to prioritize tasks and work across locations and time zones.
• Demonstrated ability to adapt to changing priorities and work effectively in a matrix organization.
• Demonstrated track record of leading promotional copy review and approval teams and of successful interactions with OPDP staff and management.
• Sense of urgency and perseverance to achieve results.
• Capable of effectively negotiating with others while maintaining composure.
• Ability 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.

Education and Experience

• 8 – 12 years experience in biotech or pharmaceutical industry with a minimum of 8 years focused in regulatory advertising & promotion.
• Advanced degree preferred (preferably in a scientific discipline).

Compensation and Benefits

The base salary range for this role is $187,520 - $234,400. Base salary is part of our total rewards package, which includes merit-based salary increases, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances, and leaves in line with work state. Our time-off policy includes flexible paid time off, 11 paid holidays, additional time off during a December shutdown, and paid sick time. Total compensation will depend on candidate experience, skills, education, and other factors allowed by law.

Compliance and Equal Employment Opportunity

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer. Qualified applicants will be considered for employment 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 characteristic protected by law.

Notes

All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. This description outlines the general nature and level of work and is not exhaustive of all responsibilities, duties, and skills required.