Associate Director, Regulatory Affairs
5 days ago
Veloxis Pharmaceuticals is an Asahi-Kasei Group Company based in Cary, NC. Our purpose is to transform transplant medicine as the primary partner to the community of transplant healthcare providers and their patients; our focus is in developing new therapies and programs to help transplant healthcare providers and the patients they treat. Veloxis provides a dynamic and innovative place to work that encourages professional development and embraces diversity. We seek creative, intelligent, action-oriented, and passionate individuals who thrive in a collaborative team environment. If you are interested in being part of a patient-centric company, then we invite you to learn more about the employment opportunities available at Veloxis. Our success is tied to the contribution of every team member, which is why we provide a valuable and competitive compensation package that includes health and insurance benefits, training, and development opportunities, as well as performance-based bonus eligibility.
Company:
Veloxis Pharmaceuticals, Inc.
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 manages FDA advisory comment requests, 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.
- 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%
#LI-AS1 #Hybrid
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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