Sumitomo Pharma
Director, Regulatory Advertising & Promotion
Sumitomo Pharma, Denver, Colorado, United States, 80285
Overview
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company 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. 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. The role primarily serves as the Regulatory reviewer for assigned products, providing strategic guidance on the advertising and promotion of those products, balancing regulatory requirements with business needs. The 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
Advertising & Promotion Review Activities: review and approve materials that comply with applicable external advertising & promotional regulations or codes of practice (e.g., FDA regulations, PhRMA guidelines) and align with company guiding principles; align with regulatory colleagues on strategies to optimize commercial success for clinical trials and labeling.
Develop and maintain productive relationships with colleagues and vendors involved in development, review, and approval of promotional materials (e.g., Marketing and their agencies, Legal, Compliance, Medical Affairs); provide oversight of promotional material review and ensure on-time submission 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 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.
Core Competencies
Strong verbal and written communication, interpersonal, listening, and organizational skills with the ability to influence internally and externally.
Unquestionable ethics and integrity aligned with SMPA values; ability to work in a diverse environment; prioritize tasks across locations/time zones.
Proven ability to adapt to changing priorities in a matrix organization; track record of leading promotional copy review and approval with OPDP interactions; sense of urgency and perseverance.
Negotiation skills, ability to defend difficult positions, and willingness to learn new therapeutic areas; comfort presenting to all levels of the organization including Senior Management.
Education and Experience
8–12 years in biotech or pharmaceutical industry with a minimum of 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. Base salary is part of the total rewards package, which includes merit-based increases, eligibility for the 401(k) plan, medical/dental/vision/life and disability insurances, and leaves in line with work state. The time-off policy includes flexible paid time off, 11 paid holidays, additional time off during a December shutdown, and 80 hours of paid sick time per year. Total compensation will depend on candidate experience, skills, education, and other factors permitted by law. Compliance, Confidentiality & Equal Opportunity
Confidential Data : All information encountered is confidential. Compliance : Achieve and maintain compliance with regulatory and legal requirements, ensuring plans and activities for SMPA and affiliates follow best industry practices and high ethical standards. Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer. Qualified applicants will be considered without regard to protected characteristics as defined by law. Our Mission and Vision : Our work is guided by the Sumitomo Pharma mission and values.
Mission:
To broadly contribute to society through value creation based on innovative research and development for better healthcare worldwide.
Vision:
For Longer and Healthier Lives, unlocking the future with cutting-edge technology and ideas.
#J-18808-Ljbffr
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company 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. 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. The role primarily serves as the Regulatory reviewer for assigned products, providing strategic guidance on the advertising and promotion of those products, balancing regulatory requirements with business needs. The 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
Advertising & Promotion Review Activities: review and approve materials that comply with applicable external advertising & promotional regulations or codes of practice (e.g., FDA regulations, PhRMA guidelines) and align with company guiding principles; align with regulatory colleagues on strategies to optimize commercial success for clinical trials and labeling.
Develop and maintain productive relationships with colleagues and vendors involved in development, review, and approval of promotional materials (e.g., Marketing and their agencies, Legal, Compliance, Medical Affairs); provide oversight of promotional material review and ensure on-time submission 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 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.
Core Competencies
Strong verbal and written communication, interpersonal, listening, and organizational skills with the ability to influence internally and externally.
Unquestionable ethics and integrity aligned with SMPA values; ability to work in a diverse environment; prioritize tasks across locations/time zones.
Proven ability to adapt to changing priorities in a matrix organization; track record of leading promotional copy review and approval with OPDP interactions; sense of urgency and perseverance.
Negotiation skills, ability to defend difficult positions, and willingness to learn new therapeutic areas; comfort presenting to all levels of the organization including Senior Management.
Education and Experience
8–12 years in biotech or pharmaceutical industry with a minimum of 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. Base salary is part of the total rewards package, which includes merit-based increases, eligibility for the 401(k) plan, medical/dental/vision/life and disability insurances, and leaves in line with work state. The time-off policy includes flexible paid time off, 11 paid holidays, additional time off during a December shutdown, and 80 hours of paid sick time per year. Total compensation will depend on candidate experience, skills, education, and other factors permitted by law. Compliance, Confidentiality & Equal Opportunity
Confidential Data : All information encountered is confidential. Compliance : Achieve and maintain compliance with regulatory and legal requirements, ensuring plans and activities for SMPA and affiliates follow best industry practices and high ethical standards. Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer. Qualified applicants will be considered without regard to protected characteristics as defined by law. Our Mission and Vision : Our work is guided by the Sumitomo Pharma mission and values.
Mission:
To broadly contribute to society through value creation based on innovative research and development for better healthcare worldwide.
Vision:
For Longer and Healthier Lives, unlocking the future with cutting-edge technology and ideas.
#J-18808-Ljbffr