Sumitomo Pharma is hiring: Director of Regulatory Advertising and Promotion in O

Sumitomo Pharma Co., Ltd. is a global pharmaceutical innovator based in Japan, with operations in the U.S. through Sumitomo Pharma America, Inc. Our focus is on addressing patient needs across multiple therapeutic areas, including oncology, urology, women's health, rare diseases, cell & gene therapies, and CNS. With a robust portfolio of marketed products and a promising pipeline of investigational assets, we are dedicated to accelerating research and development to deliver novel therapies to patients more rapidly.

We are excited to invite applications for the role of Director of Regulatory Advertising and Promotion. As a crucial member of our Global Regulatory Affairs (GRA) team, this position primarily involves acting as the Regulatory reviewer for assigned products. In this role, you will provide strategic and expert guidance on the advertising and promotion of our products, skillfully navigating regulatory requirements while aligning with business objectives. This position offers autonomy and the opportunity to mentor junior staff or supervise external consultants.

Key Responsibilities:

• Review and approve advertising and promotional materials to ensure compliance with FDA regulations and PhRMA guidelines while maintaining alignment with company principles.
• Collaborate with regulatory colleagues to develop strategies that enhance the commercial success of products, including clinical trials and labeling.
• Foster productive relationships with marketing teams, legal, compliance, and medical affairs for the development and review of promotional materials.
• Oversee the review of promotional materials, ensuring timely and accurate submissions to regulatory agencies.
• Cultivate a working relationship with the Office of Prescription Drug Promotion (OPDP) at the FDA.
• Act as the internal regulatory expert on FDA regulations and enforcement trends in prescription therapy promotion.
• Contribute to the creation and review of SOPs and department operating procedures.

Talent Management:

• Provide training and mentorship to junior staff and oversee external consultants as needed.

Core Competencies:

• Exceptional verbal and written communication skills with the ability to influence stakeholders effectively.
• Unwavering ethics and professional integrity aligned with SMPA values.
• Capability to thrive in a diverse environment and manage multiple priorities across various locations.
• Demonstrated adaptability to shifting priorities in a matrixed organization.
• Proven experience leading promotional copy review teams and successful interactions with OPDP staff.
• Strong negotiation skills and the ability to maintain composure under pressure.
• A willingness to learn and adapt to new therapeutic areas.
• Competence in making complex decisions and defending challenging positions.
• Comfortable presenting to all levels of the organization, including senior management.

Education and Experience:

• 8 - 12 years of experience in the pharmaceutical or biotech industry, with at least 8 years focused on regulatory advertising and promotion.
• Advanced degree preferred, ideally in a scientific discipline.

The base salary range for this role is $187,520 to $234,400. This position is a key component of our total rewards package, which includes opportunities for merit-based salary increases, participation in a short incentive plan, and a comprehensive benefits package. Our robust time-off policy includes unlimited paid time off, 11 paid holidays, additional time off during a company-wide shutdown in late December, and 80 hours of paid sick leave upon hire and annually thereafter. Total compensation, including the base salary offered, will reflect unique qualifications such as experience, skills, and education.

Disclaimer: The statements above describe the nature and level of work performed by individuals assigned to this position and are not exhaustive of all responsibilities and skills required. All personnel may be tasked with duties outside of their usual responsibilities as necessary.

Confidential Data: All information encountered by employees is considered confidential.

Compliance: Ensure adherence to all regulatory, legal, and operational rules and standards, carrying out all activities with the highest ethical standards.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment. Violations of this law may result in penalties.

Mental/Physical Requirements: This role operates in a fast-paced environment requiring effective judgment, initiative, and independence. Excellent communication skills and the ability to use a personal computer for extended durations are essential.

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer. Qualified applicants will receive consideration without regard to race, color, creed, religion, national origin, age, sex, disability, veteran status, or any other characteristic protected by law.

SMPA is committed to making the application process accessible. If you need assistance due to a disability or other requirements, please reach out to us. This contact information is for accommodation requests only and cannot be used to check application status.

At Sumitomo Pharma America, our mission is to contribute to society by creating value through innovative research and development for improved healthcare and quality of life worldwide.

Our Vision: For Longer and Healthier Lives, we unlock the future with cutting-edge technology and ideas.