Associate Director, Regulatory

PharmaEssentia U.S.A.

3d•$185,000 - $225,000

About The Position

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 PharmaEssentia USA. Join us, and let’s transform lives, together. PharmaEssentia 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. Position Overview The Associate Director, Regulatory, within the Compliance & Legal department, leads compliance-focused regulatory review and governance for promotional materials across media types (print, digital, social, and broadcast) for the Company’s products within an assigned product/therapeutic area. Serving as the Compliance & Legal representative on the promotional review committee (MLR/PRC; PRC/SRC/MRC as applicable), this role provides strategic input early in campaign concept and copy development, ensures alignment with internal policies and external standards (FDA/OPDP, FTC, the PhRMA Code, and other applicable laws and—when needed—relevant global requirements), and manages Form FDA 2253 submissions and OPDP advisory comment requests as appropriate. The role also helps define and maintain SOPs, controls, and training for the review process, monitors evolving guidance and enforcement trends, and maintains documentation and audit readiness to support inspections and audits.

Requirements

Bachelor’s degree in a scientific discipline, pharmacy, public health, or a related field
7+ years of experience in U.S. pharmaceutical/biotech compliance, regulatory affairs, or medical review focused on advertising and promotion
Demonstrated experience serving on MLR/PRC for promotional and non-promotional materials
Experience providing compliance-focused risk assessments to cross-functional teams on promotional materials and activities for marketed products
Strong working knowledge of FDA advertising and promotion requirements, including OPDP interactions, 21 CFR 202.1, and Form FDA 2253 submissions; Subpart E experience as applicable
Familiarity with U.S. product labeling development and maintenance, and the connection between labeling and permissible promotional claims
Experience maintaining documentation and audit readiness for promotional materials and labeling records, including supporting inspections and audits
Ability to translate regulations into practical guidance, SOPs, workflows, and controls that enable timely, compliant execution
Proven cross-functional influence and stakeholder management skills, with excellent written and verbal communication
Demonstrated judgment and integrity, with comfort identifying and escalating compliance risks, deviations, and policy exceptions

Responsibilities

Lead compliance-focused regulatory review of promotional materials across media types (print, digital, social, and broadcast) for the Company’s products within the assigned product/therapeutic area
Ensure promotional content and materials comply with FDA regulations (including 21 CFR 202.1), FTC requirements, the PhRMA Code, and other applicable laws
Ensure submissions of promotional materials to FDA (Form FDA 2253) and FDA Office of Prescription Drug Promotion (OPDP) advisory comment requests
Build and maintain strategic relationships with regulatory authorities
Identify, escalate, and help resolve compliance risks and potential violations related to promotional practices, including deviations and policy exceptions as applicable, partnering with Legal, Compliance, and business stakeholders
Support audits and inspections related to promotional and labeling compliance, including ensuring appropriate documentation, audit readiness, and timely responses
Serve as a representative on the promotional review committee (MLR/PRC; PRC/SRC/MRC as applicable), providing guidance and ensuring alignment with internal policies and external compliance standards
Provide guidance on regulatory and compliance requirements for the SOPs, workflows, and controls used to develop, review, approve (MLR/PRC), and submit marketing materials
Provide strategic input during early campaign concept and copy development to streamline MLR/PRC review and approval
Lead and/or support training for commercial teams on FDA advertising and promotion requirements, including Subpart E and Form FDA 2253 submission expectations as applicable
Establish strong partnerships and governance with key internal stakeholders to enable consistent interpretation and compliant execution
Partner across Compliance & Legal to support effective MLR/PRC governance, timely cross-functional review, and well-documented decisions
Monitor evolving regulatory guidance and enforcement trends and apply relevant updates to review processes, SOPs, and training materials
Provide solution-oriented, innovative compliance and regulatory guidance that supports the Company’s objectives while appropriately managing risk
Monitor the evolving regulatory environment and maintain current knowledge to proactively provide compliant, practical recommendations
Seek and incorporate diverse perspectives across the Company and externally to strengthen risk assessments and mitigation strategies
Identify and contribute to process improvements to increase the efficiency and effectiveness of the ad/promo review function
Support colleagues within the Compliance & Legal department by sharing knowledge, providing coaching, and contributing to team development