Associate Director, Regulatory Affairs Advertising & Promotion Compliance

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 disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Summary:

The Associate Director, Regulatory Affairs, Advertising and Promotion Compliance will independently review, approve, and monitor product advertising and promotional labeling material for an assigned product to ensure compliance with US regulatory requirements.  In addition, the associate director 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:

•    The Associate Director is responsible for providing strategic and tactical regulatory support and guidance for assigned product and disease state communications as well as pipeline and non-promotional communications.
•    Provides guidance and input for assigned development products reflective of promotional considerations, including assessment of potential labeling claims
•    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.  Works collaboratively with cross-functional partners, including Legal and Medical as part of PRC. Develops solutions to complex promotional issues by utilizing scientific and regulatory knowledge to support business objectives and initiatives while effectively identifying, escalating, and managing business risks.  
•    Serves as the regulatory reviewer for the Medical Review Process (MRC) for assigned product(s).
•    Provides direction and works collaboratively to ensure that changes in US Prescribing Information are reflected in current promotions and advertising
•    Continually assesses the advertising and promotion related
process to enhance efficiencies and compliance. 
•    Collaborates in cross-functional efforts to develop, update, and implement policies, procedures and guidelines related to Regulatory Advertising and Promotion Compliance.
•    Primary liaison with Office of Prescription Drug Promotion (OPDP) regarding advertising and promotion for assigned products
•    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 regulatory compliance training to staff and cross-functional partners from a regulatory perspective.

Requirements:

Education
Advance degree preferred (Pharm.D., Phd, M.S, JD, etc).

Experience
•    Minimum of 5 years’ experience in  Advertising and Promotion as a primary reviewer of promotional and nonpromotional materials with an advanced degree, such as Pharm.D.  
•    Minimum 8 years’ experience in Advertising and Promotion as a primary reviewer of promotional and nonpromotional materials with Bachelor’s degree.

Job-Related Skills
•    Thorough knowledge of applicable regulations, guidance, and industry standards related to advertising and promotional communications about prescription drugs, devices (if applicable), and investigational treatments in the US
•    Understanding of clinical study design and statistical analyses in assessment of promotional claims
•    Strong interpersonal and communication skills and ability to communicate difficult concepts and influence others

Non-Technical Skills
Highly motivated and great attention to detail. Should have the ability to promptly assess documents for accuracy as well as consistency. Strong endurance to work under tight timelines and complex/ changing situations. Excellent presentation and communication skills. Thinks strategically and can demonstrate leadership. Exceptional detail-oriented focus, with the ability to promptly assess documents for accuracy as well as consistency. Strong written and oral communication skills and the ability to interact effe