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 FDAs Office of Prescription Drug Promotion (OPDP) as well as submissions to PAAB for promotional materials in Canada, 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/Health Canada 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 and Canadian Product Monograph 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 and Canadian regulatory promotional environment and stays 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. • 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: Bachelor's degree in life science or closely related discipline. Advance degree preferred (Pharm.D., Phd, M.S, JD)
Experience: • 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 consumer and professional marketing materials. • Familiarity with launch planning, including pre-approval communications, disease awareness campaigns, and launch materials. • Experience with training Commercial and cross-functional teams on promotional compliance principles, regulatory changes, and industry best practices. • Preferred, but not required, experience with reviewing promotional and non-promotional communications in Canada to be compliant with Health Canada regulations.
Technical 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. • Excellent written, verbal, and presentation skills, with the ability to communicate effectively across all levels of the organization. • Solid proficiency using Microsoft Office Suite including Word, Excel, and Power Point for documentation, analysis, and presentations. • Experience with Veeva, SharePoint and Box
Working Conditions: Requires up to 10% domestic and international travel
Salary and Benefits: The anticipated salary for this position will be $ to $. 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 match 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 Life & Disability Insurance Concierge Services Long Term Incentive Program (subject to job level and performance) Pet Insurance Tuition Assistance Employee Referral Awards
Equal Employment Opportunity: 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.