BioSpace, Inc. is hiring : Head of Regulatory Advertising and Promotion in Baskin

Job Details

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.
• Serve as the primary regulatory advisor to cross-functional teams, including marketing, medical affairs and legal, to align promotional strategies with regulatory requirements.
• 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

Download Our Benefits Summary PDF

Company

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 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 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.

For more information, please visit : www.daiichisankyo.com .

Daiichi Sankyo, Inc., headquartered in Basking Ridge, New Jersey, is a member of the Daiichi Sankyo Group. To learn more about Daiichi Sankyo, Inc., please visit www.dsi.com .

STOCK EXCHANGE : Tokyo Stock Exchange

STOCK SYMBOL : 4568

Company info

Website http : / / www.daiichisankyo.com / Phone (908) 992-6400 Location 211 Mt. Airy Road

Basking Ridge

New Jersey

07920

United States

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