Director, Regulatory Advertising & Promotion

Location:

Burlington, MA (hybrid with 3 days per week in office) The Company:

It’s not often you get the chance to make a real impact on the lives of others, while expanding your own possibilities. You’ll find that rare opportunity at Pharma Essentia USA. Join us, and let’s transform lives, together.

Pharma Essentia USA Corporation is a rapidly growing biopharmaceutical innovator. We are leveraging deep expertise and proven scientific principles to deliver effective new biologics for challenging diseases in the areas of hematology and oncology, with one product approved in Europe and a diversifying pipeline. We believe in the potential to improve both health and quality of life for patients with limited options today through the combination of rigorous research and innovative thinking.

Founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today we are listed on the Taipei Exchange (6446) and are expanding our global presence with operations in the U.S., Japan, and China, along with a world-class biologics production facility in Taichung.

The Director, Regulatory Advertising & Promotion, within the Compliance & Legal department, provides strategic leadership and oversight for regulatory review, promotional governance, and compliance risk management across the Company’s advertising and promotional activities. This role serves as a senior regulatory and compliance leader on the promotional review committee (MLR/PRC; PRC/SRC/MRC as applicable), guiding the development, review, approval, and submission of promotional materials across media types, including print, digital, social, and broadcast.

The Director partners closely with Commercial, Medical, Legal, Compliance, Regulatory, and other cross‑functional stakeholders to ensure promotional strategies and materials are scientifically accurate, appropriately substantiated, aligned with approved labeling, and compliant with FDA/OPDP, FTC, the PhRMA Code, internal policies, and other applicable requirements. This role also leads the development and continuous improvement of ad/promo SOPs, governance processes, controls, training, documentation practices, inspection readiness, Form FDA 2253 submissions, and OPDP advisory comment requests as appropriate.

• Provide strategic leadership and oversight for compliance-focused regulatory review of promotional materials across media types, products, and therapeutic areas as assigned
• Establish and maintain a consistent, risk-based framework to ensure promotional content and materials comply with FDA regulations, including 21 CFR 202.1, FTC requirements, the PhRMA Code, internal policies, and other applicable laws
• Oversee timely and accurate submission of promotional materials to FDA, including Form FDA 2253 submissions and FDA Office of Prescription Drug Promotion (OPDP) advisory comment requests, as appropriate
• Build and maintain strategic relationships with regulatory authorities and represent the Company in relevant regulatory interactions related to advertising and promotion
• Lead identification, escalation, and resolution of promotional compliance risks, potential violations, deviations, and policy exceptions, partnering with Legal, Compliance, Commercial, Medical, and Regulatory stakeholders
• Direct audit and inspection readiness activities related to promotional and labeling compliance, ensuring appropriate documentation, governance evidence, and timely responses to requests

• Serve as a senior regulatory and compliance leader on the promotional review committee (MLR/PRC; PRC/SRC/MRC as applicable), providing strategic guidance, decision‑making support, and alignment with internal policies and external compliance standards
• Lead development, implementation, and continuous improvement of SOPs, workflows, and controls used to develop, review, approve, and submit promotional materials
• Provide strategic input during early brand planning, campaign concept development, and copy development to enable compliant, efficient, and business‑aligned MLR/PRC…