Associate Director, Regulatory Affairs Advertising & Promotion Compliance
The Associate Director of Regulatory Affairs, Advertising and Promotion Compliance at Kyowa Kirin North America is responsible for ensuring that all promotional materials for assigned products comply with U.S. and Canadian regulatory requirements. This role involves reviewing, approving, and monitoring advertising and promotional labeling materials to maintain compliance with FDA and Health Canada regulations. The position is based in Princeton, New Jersey, and reports to the Director of Regulatory Affairs.
Key responsibilities include serving as the Promotional Review Committee (PRC) chair, providing strategic and tactical regulatory support for assigned products, and collaborating with cross-functional teams such as Legal and Medical to develop solutions to complex promotional issues. The Associate Director will also be responsible for preparing FDA Form 2253 submissions, managing communications with the FDA's Office of Prescription Drug Promotion (OPDP), and ensuring that promotional materials reflect current prescribing information. Additionally, the role involves monitoring the regulatory environment to stay abreast of changes and providing relevant training to staff and cross-functional partners.
Candidates should possess a Bachelor's degree in life science or a closely related discipline, with an advanced degree preferred. A minimum of seven years of progressive experience in the pharmaceutical or biotechnology industry, specifically in Regulatory Affairs with a focus on Advertising and Promotion, is required. Proven experience as the primary regulatory reviewer for promotional and non-promotional materials across various therapeutic areas is essential. Strong experience in leading and managing Regulatory review processes within cross-functional Medical, Legal, and Regulatory teams is also necessary. Familiarity with launch planning, including pre-approval communications and disease awareness campaigns, is beneficial. Experience with reviewing promotional and non-promotional communications in Canada to ensure compliance with Health Canada regulations is preferred but not required.
The compensation package includes a competitive salary, comprehensive health benefits, and opportunities for professional development. Kyowa Kirin North America offers a collaborative work environment that encourages innovation and growth. Employees have access to various wellness programs and are supported in maintaining a healthy work-life balance.
Kyowa Kirin North America is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in areas such as bone and mineral, intractable hematologic, hematology oncology, and rare diseases. The company is headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. Kyowa Kirin is committed to translating science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization.