Director, Regulatory Advertising & Promotion Job at Sumitomo Pharma in Pierre

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

Responsibilities

• Advertising & Promotion Review Activities: 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 and their Agencies, Legal, Compliance, and Medical Affairs.
• Provide appropriate 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.

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

Key Core Competencies

• Strong verbal and written communication, interpersonal, listening, and organizational skills with the ability to influence internally and externally.
• Unquestionable ethics, professional integrity, and personal values aligned with SMPA values.
• Ability to work in a diverse environment and across locations/time zones.
• Ability to prioritize tasks and adapt to changing priorities in a matrix organization.
• Proven track record of leading promotional copy review and approval teams and interactions with OPDP staff and management.
• Sense of urgency, perseverance, negotiation skills, and ability to defend difficult positions when needed.
• Ability to learn new therapeutic areas and make complex decisions.
• Comfortable presenting to all levels of the organization, including Senior Management.

Education and Experience

• 8–12 years of experience in biotech or pharmaceutical industry with at least 8 years focused on 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. This includes the opportunity for merit-based salary increases and eligibility for our 401(k), medical, dental, vision, life and disability insurances, and leaves outlined by state law. The company provides a robust time-off policy including flexible paid time off, holidays, and sick time in accordance with applicable law.

Compliance and EEO

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer. Qualified applicants will receive consideration for employment without regard to protected characteristics as defined by law. Additional compliance statements and confidentiality expectations are included as part of employee responsibilities.