Apply on Employer Site

Veloxis Pharmaceuticals, Inc. · 21 hours ago

Associate Director, Regulatory Affairs - Advertising & Promotion

Cary, NC

Full-time

Hybrid

Senior Level, Lead/Staff, Director/Executive

7+ years exp

Veloxis Pharmaceuticals, Inc. is part of the Asahi Kasei Group, committed to transforming transplant medicine. The Associate Director, Regulatory Affairs – Advertising & Promotion will lead regulatory oversight of promotional activities, ensuring compliance with FDA regulations and providing strategic regulatory guidance to cross-functional teams.

BiotechnologyHealth CareMedicalPharmaceutical

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

Qualification

Regulatory AffairsFDA RegulationsPromotional ReviewRisk ManagementCross-functional CollaborationInterpersonal SkillsOrganizational SkillsCommunication SkillsTime Management

Required

Bachelor's degree in a scientific discipline required

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

Preferred

advanced degree (PharmD, JD, MBA, or equivalent)

Benefits

Health and insurance benefits

Training and development opportunities

Performance-based bonus eligibility

Company

Veloxis Pharmaceuticals, Inc.

Veloxis Pharmaceuticals, Inc., an Asahi Kasei company, is a fully integrated specialty pharmaceutical company committed to improving the lives of transplant patients.

Founded in 2002

Hørsholm, Hovedstaden, DNK

51-200 employees