Director, Regulatory Advertising & Promotion. Job in Des Moines Move Collective

Director, Regulatory Advertising & Promotion
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company with operations in the U.S. focused on oncology, urology, women's health, rare diseases, cell & gene therapies, and CNS. We aim to accelerate discovery, research, and development to bring novel therapies to patients sooner.

Responsibilities

Review and approve materials that comply with relevant external advertising & 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, Legal, Compliance, 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 team 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 willingness to 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 minimum of 8 years focused in regulatory advertising & promotion.

Advanced degree preferred (preferably in a scientific discipline).

The base salary range for this role is $187,520 to $234,400. Base salary is part of a total rewards package that includes merit‑based salary increases, a short‑incentive plan, eligibility for 401(k), medical, dental, vision, life and disability insurance, and leaves consistent with state regulations. Our robust time‑off policy includes unlimited paid time off, 11 paid holidays, additional time off for a shutdown period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter.

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, sexual orientation, disability, veteran or military status, domestic violence victim status, genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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