Kyowa Kirin is a fast growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four areas of unmet need: oncology, nephrology, immunology and CNS/movement disorders. The North America organization includes three offices (in New Jersey and California) that focus on drug discovery, product development, and commercialization. Together, we work as a close-knit team to understand clinical needs and advance innovations that can have a profound impact on patient lives.
As a patient centric organization that strives to deliver innovative medicines to meet unmet needs. We feel that it is critical to follow the safety guidelines defined by CDC and OSHA, including receiving the COVID-19 vaccine as the best way to manage COVID risk to you, your colleagues, your family and our society. With that in mind, we are taking the essential step to ensure the safety of our employees during this health crisis. The decision has been made to require all US employees, temporary workers, agency employees and independent contractors to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. In accordance with applicable law, individuals may seek an accommodation for medical or disability-related conditions or sincerely held religious beliefs.
The Manager, Regulatory Affairs, Advertising and Promotion Compliance will review, approve and monitor product advertising and promotional labeling material for an assigned product to ensure compliance with US regulatory requirements. In addition, the manager will be responsible for supporting preparation of FDA Form 2253 submissions and any requests for advisory comment submissions to FDA's Office of Prescription Drug Promotion (OPDP), as applicable.
* Provides regulatory guidance regarding advertising and promotional materials.
* Serves as Promotional Review Committee (PRC) chair and as the primary regulatory reviewer of advertising, promotions and other related materials for assigned product to ensure compliance with applicable FDA laws, regulations and guidance.
* Provide Ad/Promo expertise and guidance to the development of FDA labeling for both new and approved products
* Establishes and maintains a collaborative relationship with cross-functional partners, such as Legal, Medical, Marketing, and Communications
* Helps to ensure that changes in US Prescribing Information are reflected in current promotions and advertising.
* Monitors US regulatory promotional environment and stays abreast of all relevant regulatory and industry changes and updates related to FDA guidance, warning letters, enforcement actions and regulations; and communicate to appropriate internal and external personnel in a timely manner, highlighting the Implications of the changes.
* Ensures the maintenance of paper and electronic records of all submissions and communications with OPDP, and any supporting documentation...
* Provide relevant compliance training to staff from a
* Contribute to the development and Implementation of corporate and department policies and procedures related to Advertising, Promotion and Regulatory Compliance.
* Continually assesses the advertising and promotion related
process to enhance efficiencies and compliance.
* Support/lead GRA Compliance and Planning initiatives.
Bachelor's degree or Advance degree preferred (Pharm D, Phd, M.S, JD, etc).
5 years or more pharmaceutical industry experience and 3 years or more in Regulatory Affairs as a primary reviewer of promotional materials.
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
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