Sr. Manager- Regulatory Affairs, Advertising and Promotion Compliance
Bedminster, NJ 
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Job Description

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.

Summary:

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.

Essential Functions:

* 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
regulatory perspective.
* 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.

Requirements:

Education
Bachelor's degree or Advance degree preferred (Pharm D, Phd, M.S, JD, etc).

Experience
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.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. ("Controller"), which is located at 135 Route 202/206, Suite 6, Bedminster, NJ 07921 USA and can be contacted by emailing kkus.talentacquisition8h@kyowakirin.com. Controller's data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller's recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 ("GDPR") as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller's behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.


Individuals seeking employment at Kyowa Kirin, Inc. are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action recordkeeping, reporting, and other legal requirements.

 

Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Experience
5+ years
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