Veloxis Pharmaceuticals, Inc.
Associate Director, Regulatory Affairs - Advertising & Promotion
Veloxis Pharmaceuticals, Inc., Cary, North Carolina, United States, 27518
Company
Veloxis Pharmaceuticals, Inc. is an Asahi-Kasei Group company based in Cary, NC. Its purpose is to transform transplant medicine as a primary partner to community transplant healthcare providers and their patients. We develop new therapies and programs to help transplant healthcare providers and the patients they treat, fostering a dynamic, innovative workplace that encourages professional development and embraces diversity.
Job Description The Associate Director, Regulatory Affairs – Advertising & Promotion leads and manages regulatory oversight of promotional activities for the Company's expanded healthcare product portfolio. The incumbent plays a critical role in ensuring compliance with FDA regulations, mitigating risk, accelerating time‑to‑market, and providing regulatory strategy to cross‑functional teams.
Summary of Key Responsibilities
Leads regulatory review of all promotional materials across media types (print, digital, social broadcast) for the Company's products.
Serves as the regulatory representative on the Company's Promotional Review Committee (PRC/SRC/MRC), providing regulatory guidance and ensuring alignment with internal and external compliance standards.
Ensures that promotional content complies with FDA regulations (including 21 CFS 202.1), FTC, PhRMA Code, and applicable global regulations, as necessary.
Manages submission of promotional materials to the FDA (Form 2253) and responds to FDA advisory comments as appropriate.
Provides strategic input during early campaign concept and copy development to streamline the review and approval process.
Monitors evolving regulatory guidance and enforcement trends; applies relevant updates to internal review processes and training materials.
Collaborates with Legal, Medical Affairs, and marketing departments to ensure consistent interpretation and implementation of regulatory standards.
Assists in developing and maintaining SOPs and training programs related to promotional review activities.
Participates in audits, inspections, and risk assessments related to promotional activities, and ensures appropriate documentation and response.
Identifies and implements process improvements to increase the efficiency and effectiveness of the ad/promo review function.
Required Qualifications And Skills
Bachelor’s degree in a scientific discipline required; advanced degree (PharmD, JD, MBA, or equivalent) preferred.
Minimum of 7 years of regulatory affairs experience, including significant exposure to promotional review of prescription drug and/or biologic products.
Deep understanding of FDA advertising and promotion regulations and guidance.
Proven ability to interpret and apply regulatory guidance in a practical, risk‑managed manner.
Experience serving on PRC/SRC/MRC teams and working cross‑functionally with commercial, medical, and legal stakeholders.
Strong interpersonal, organizational, and communication skills.
Ability to manage multiple priorities and deliver under tight timelines in a dynamic environment.
Travel Requirements Approximately 10%.
Work Arrangement Hybrid.
Seniority Level Mid‑Senior level.
Employment Type Full‑time.
Job Function Legal.
Equal Opportunity Employer Statement As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.
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Job Description The Associate Director, Regulatory Affairs – Advertising & Promotion leads and manages regulatory oversight of promotional activities for the Company's expanded healthcare product portfolio. The incumbent plays a critical role in ensuring compliance with FDA regulations, mitigating risk, accelerating time‑to‑market, and providing regulatory strategy to cross‑functional teams.
Summary of Key Responsibilities
Leads regulatory review of all promotional materials across media types (print, digital, social broadcast) for the Company's products.
Serves as the regulatory representative on the Company's Promotional Review Committee (PRC/SRC/MRC), providing regulatory guidance and ensuring alignment with internal and external compliance standards.
Ensures that promotional content complies with FDA regulations (including 21 CFS 202.1), FTC, PhRMA Code, and applicable global regulations, as necessary.
Manages submission of promotional materials to the FDA (Form 2253) and responds to FDA advisory comments as appropriate.
Provides strategic input during early campaign concept and copy development to streamline the review and approval process.
Monitors evolving regulatory guidance and enforcement trends; applies relevant updates to internal review processes and training materials.
Collaborates with Legal, Medical Affairs, and marketing departments to ensure consistent interpretation and implementation of regulatory standards.
Assists in developing and maintaining SOPs and training programs related to promotional review activities.
Participates in audits, inspections, and risk assessments related to promotional activities, and ensures appropriate documentation and response.
Identifies and implements process improvements to increase the efficiency and effectiveness of the ad/promo review function.
Required Qualifications And Skills
Bachelor’s degree in a scientific discipline required; advanced degree (PharmD, JD, MBA, or equivalent) preferred.
Minimum of 7 years of regulatory affairs experience, including significant exposure to promotional review of prescription drug and/or biologic products.
Deep understanding of FDA advertising and promotion regulations and guidance.
Proven ability to interpret and apply regulatory guidance in a practical, risk‑managed manner.
Experience serving on PRC/SRC/MRC teams and working cross‑functionally with commercial, medical, and legal stakeholders.
Strong interpersonal, organizational, and communication skills.
Ability to manage multiple priorities and deliver under tight timelines in a dynamic environment.
Travel Requirements Approximately 10%.
Work Arrangement Hybrid.
Seniority Level Mid‑Senior level.
Employment Type Full‑time.
Job Function Legal.
Equal Opportunity Employer Statement As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.
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