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Associate Director, Regulatory Affairs Advertising & Promotion Compliance

Princeton, New Jersey

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 effectively with cross functional project teams.

Working Conditions:

Requires up to 10% domestic and international travel

The anticipated salary for this position will be $170,000 to $190,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

  • 401K with company matching
  • Discretionary Profit Sharing
  • Annual Bonus Program (Sales Bonus for Sales Jobs)
  • Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
  • Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
  • HSA & FSA Programs
  • Well-Being and Work/Life Programs
  • Long-Term Incentives
  • Life & Disability Insurance
  • Concierge Service
  • Pet Insurance
  • Tuition Assistance
  • Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

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 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@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. 

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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.

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Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

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