BioSpace is hiring : Head of Regulatory Advertising and Promotion in Basking Ridg

Head of Regulatory Advertising and Promotion

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Job Summary

The Head of Regulatory Advertising and Promotion (RAAP) will lead and oversee all regulatory activities related to the review, approval, and compliance of advertising and promotional materials for the company\'s pharmaceutical products. This leadership role is critical in ensuring that all promotional strategies align with FDA regulations, industry standards, and corporate objectives while effectively supporting commercial goals. This role also involves managing a team of regulatory professionals, fostering collaboration across departments, and maintaining a proactive approach to regulatory risk management and industry engagement. The individual will serve as the primary regulatory advisor for cross-functional teams, including marketing, medical affairs, and legal, on the product material review team (PMRT), and will act as the main point of contact with the FDA\'s Office of Prescription Drug Promotion (OPDP). This individual must have comprehensive knowledge of FDA regulations, including labeling requirements and promotional guidelines, as well as experience in assessing the impact of labeling language on promotional strategies to ensure compliance and alignment with commercial objectives. This individual will also play a pivotal role in collaborating with our alliance partners to align regulatory strategies and promotional practices.

Responsibilities

• Strategic Leadership : Develop and implement regulatory strategies for advertising and promotional materials to ensure compliance with FDA regulations (e.g., OPDP requirements) and other applicable guidelines.
• Strategic Leadership : Serve as the primary regulatory advisor to cross-functional teams, including marketing, medical affairs and legal, to align promotional strategies with regulatory requirements.
• Strategic Leadership : Assess the impact of labeling language on promotional strategies to ensure compliance and alignment with commercial objectives. Work closely with alliance partners to align regulatory strategies and ensure consistency in promotional practices across joint initiatives. Address and resolve regulatory challenges that arise in alliance partner collaborations.

Review And Approval Of Promotional Materials

Team Leadership

Compliance And Risk Management

Regulatory Intelligence

Qualifications

Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education

Experience

Travel

Daiichi Sankyo, Inc. is an equal opportunity / affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Salary Range

$238,275.00 - $397,125.00

#J-18808-Ljbffr