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

Overview

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company focused on oncology, urology, women’s health, rare diseases, psychiatry & neurology, and cell & gene therapies. We operate in the U.S., Canada, and Europe, with a diverse pipeline and a commitment to accelerating discovery, research, and development to bring novel therapies to patients. For more information on SMPA, visit our website.

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. He/she will primarily function as the Regulatory reviewer for assigned products and provide strategic, expert guidance on the advertising and promotion of those products, balancing regulatory requirements with business needs. This position 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.

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 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.
• May train/mentor junior staff and/or oversee external consultants as part of Talent Management.

Qualifications

• 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).

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).

Compensation and Benefits

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

Compliance and Equal Opportunity

Disclaimer: The statements describe the general nature and level of work performed and are not exhaustive. All personnel may be required to perform duties outside of their normal responsibilities as needed. Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer. Qualified applicants will receive consideration without regard to protected characteristics.