Associate Director, Regulatory Affairs Advertising & Promotion Compliance

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.

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 well as submissions to PAAB for promotional materials in Canada, as applicable.

• Provide strategic and tactical regulatory support and guidance for assigned product and disease state communications as well as pipeline and non-promotional communications.
• Provide guidance and input for assigned development products reflective of promotional considerations, including assessment of potential labeling claims.
• Serve 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/Health Canada laws, regulations, and guidance.
• Work collaboratively with cross‑functional partners, including Legal and Medical as part of PRC. Develop 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.
• Serve as the regulatory reviewer for the Medical Review Process (MRC) for assigned product(s).
• Provide direction and work collaboratively to ensure that changes in US Prescribing Information and Canadian Product Monograph are reflected in current promotions and advertising.
• Continually assess the advertising and promotion related process to enhance efficiencies and compliance.
• Collaborate in cross‑functional efforts to develop, update, and implement policies, procedures and guidelines related to Regulatory Advertising and Promotion Compliance.
• Act as the primary liaison with Office of Prescription Drug Promotion (OPDP) regarding advertising and promotion for assigned products.
• Monitor US and Canadian regulatory promotional environment and stay abreast of all relevant regulatory and industry changes and updates related to FDA and Health Canada 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.
• Ensure 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.

• Bachelor’s degree in life science or closely related discipline. Advanced degree preferred (Pharm.
  
  D., Ph.D., M.S., JD).

• Minimum five (7) years of progressive experience in the pharmaceutical or biotechnology industry, specifically in Regulatory Affairs with a focus on Advertising and Promotion (Ad/Promo).
• Proven track record as the primary regulatory reviewer for promotional and non‑promotional materials across various therapeutic areas, ensuring compliance with FDA regulations, industry guidelines (e.g., OPDP, PhRMA), and internal policies.
• Strong experience in leading and managing Regulatory review processes within cross‑functional Medical, Legal, and Regulatory (MLR) teams for both…