Associate Director, Regulatory at PharmaEssentia U.S.A.

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.

Responsibilities

Compliance & Risk Management

• 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

Cross-Functional Collaboration

• 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

Operational Excellence

• 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

Qualifications

• 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

The expected salary range for this position based on greater Boston, MA location is $185,000-$225,000. Actual salary pay will be based on multiple factors, including geographic location, experience, qualifications, and other job-related factors permitted by law.

Benefits of working with our team:
PharmaEssentia USA strives every day to improve the lives of patients as well as our employees. As a valued member of PharmaEssentia USA, you will enjoy the following benefits:

• Comprehensive medical coverage
• Dental and vision coverage
• Generous paid time-off
• 401(k) retirement plan with competitive company match
• Medical & Dependent Care Flexible Spending Account
• Up to $150 monthly cell phone reimbursement
• Employee Assistance Program
• Free parking

EEO Statement
At PharmaEssentia USA, we are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law.

PharmaEssentia USA believes that diversity and inclusion among our team are critical to our success as a global company, and we seek to recruit, develop and retain the most talented people from a diverse candidate pool. PharmaEssentia does not accept unsolicited agency resumes. Staffing agencies should not send resumes to our HR team or to any PharmaEssentia employees. PharmaEssentia is not responsible for any fees related to unsolicited resumes from staffing agencies.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

At PharmaEssentia, our goal is to treat as many people with cancer as possible. That means challenging the status quo with better science that leads to better lives. By joining our team, you will not only expand your own possibilities, but you will contribute to expanding options for people with cancer.

https://us.pharmaessentia.com/careers/