Director of Regulatory Advertising and Promotion

Sumitomo Pharma Co., Ltd. is a leading global pharmaceutical company based in Japan, with a commitment to improving patient outcomes in areas such as oncology, urology, women's health, rare diseases, cell & gene therapies, and CNS. With a rich portfolio of marketed products and an innovative pipeline, we strive to bring groundbreaking therapies to patients as swiftly as possible. To learn more about us, visit our website or follow us on LinkedIn.

We are excited to invite highly skilled and motivated individuals to apply for the position of Director of Regulatory Advertising and Promotion. This key role is part of our Global Regulatory Affairs team and primarily entails serving as the regulatory reviewer for assigned products. You will provide strategic and expert guidance on advertising and promotional efforts, ensuring alignment with regulatory standards while meeting business objectives. The position may involve mentoring junior team members and overseeing external consultants.

Key Responsibilities:

Review and approve promotional materials to ensure compliance with relevant advertising regulations and company principles.

Collaborate with regulatory colleagues to develop strategies that enhance product success during clinical trials and in labeling.

Foster productive relationships with internal teams and vendors, including Marketing, Legal, Compliance, and Medical Affairs, to ensure efficient material development and approval.

Oversee promotional material review processes and ensure timely submissions to regulatory agencies.

Establish positive working relationships with the Office of Prescription Drug Promotion at the FDA.

Act as an expert within the organization on FDA regulations and trends affecting prescription therapy promotion.

Create and review standard operating procedures and departmental processes as needed.

Talent Management:

Provide training and mentoring for junior staff and manage external consultants.

Essential Qualifications:

8-12 years of experience in the biotech or pharmaceutical industry, with at least 8 years in regulatory advertising and promotion.

An advanced degree, preferably in a scientific discipline, is preferred.

Core Competencies:

Exceptional verbal and written communication, interpersonal, and organizational skills, with the ability to positively influence others.

Strong ethical standards and professional integrity aligned with our company values.

Experience working effectively in a culturally diverse environment.

Excellent prioritization skills and ability to work across locations and time zones.

Proven leadership in promotional copy review teams and successful interactions with OPDP staff.

A sense of urgency and determination to achieve results.

Skilled in negotiation while maintaining composure under pressure.

Willingness to learn about new therapeutic areas as needed.

Aptitude for making complex decisions and defending challenging positions.

Comfortable presenting to all organizational levels, including senior management.

The base salary range for this role is $187,520 to $234,400. Your total rewards package will also include merit-based salary increases, incentive plan participation, and comprehensive benefits such as medical, dental, vision, life, and disability insurance, along with a competitive time-off policy that includes unlimited paid leave, 11 paid holidays, and additional sick leave starting at hire. Final compensation will depend on unique candidate factors including experience and education.

Disclaimer: The information provided outlines the nature of the work but is not an exhaustive list of responsibilities and skills required for the role. Employees may occasionally be asked to perform tasks beyond their standard duties as needed.

Confidential Data: All information encountered during employment is confidential.

Compliance: Ensure all regulatory, legal, and operational practices adhere to the highest ethical standards and best practices in the industry.

Mental/Physical Requirements: The role requires working in a fast-paced environment with multiple demands. You must exercise appropriate judgment, show initiative, and possess excellent written and verbal communication skills. Proficiency in using a personal computer for extended periods is also necessary.

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity employer. We consider applicants regardless of race, color, creed, religion, national origin, age, marital status, sex, gender, sexual orientation, disability, veteran status, or any other characteristic protected by law.

Additionally, SMPA is committed to making the application process accessible to all. If you need assistance, please reach out to us for accommodation requests.

As part of our hiring process, we may use Artificial Intelligence tools to assist in evaluating applications. By submitting your information, you acknowledge this usage.