Associate Director, Regulatory Affairs - Advertising & Promotion Job at Veloxis

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.