Director, Regulatory Advertising & Promotion

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

About the Company

PharmaEssentia USA Corporation is a rapidly growing biopharmaceutical innovator leveraging deep expertise and proven scientific principles to deliver effective new biologics for challenging diseases in hematology and oncology. With one product approved in Europe and a diversifying pipeline, we aim to improve both health and quality of life for patients with limited options today through rigorous research and innovative thinking. Founded in 2003 by a team of Taiwanese-American executives and renowned scientists, we are listed on the Taipei Exchange (6446) and expanding our global presence with operations in the U.S., Japan, and China, along with a world-class biologics production facility in Taichung.

About the Role

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.

Responsibilities

• Provide strategic leadership and oversight for compliance-focused regulatory review of promotional materials across media types, products, and therapeutic areas.
• Establish and maintain a consistent, risk-based framework to ensure promotional content and materials comply with FDA regulations (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 OPDP advisory comment requests.
• 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), 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 for promotional materials.
• Provide strategic input during early brand planning, campaign concept development, and copy development to enable compliant, efficient, and business-aligned MLR/PRC review and approval.
• Develop and lead training for commercial and cross-functional teams on FDA advertising and promotion requirements, OPDP expectations, Subpart E, Form FDA 2253 submissions, and internal review standards.
• Establish strong partnerships and governance practices with senior internal stakeholders to enable consistent interpretation, compliant execution, and timely decision-making.
• Monitor evolving regulatory guidance, OPDP enforcement trends, industry practices, and relevant global considerations, translating updates into actionable process, policy, and training enhancements.
• Provide solution-oriented, innovative regulatory and compliance leadership that supports Company objectives while managing business, regulatory, and reputational risk.
• Anticipate shifts in the regulatory environment and proactively advise leadership and business partners on potential impacts to promotional strategy, governance, and execution.
• Incorporate diverse perspectives to strengthen risk assessments, mitigation strategies, and decision quality.
• Lead process improvement initiatives to increase the efficiency, consistency, and effectiveness of the advertising and promotion review function.
• Provide leadership, coaching, and subject matter expertise to colleagues and cross-functional partners, contributing to team capability, knowledge sharing, and department development.

Qualifications

• Bachelor’s degree in a scientific discipline, pharmacy, public health, or a related field.
• 10+ years of progressive experience in U.S. pharmaceutical/biotech compliance, regulatory affairs, or medical review focused on advertising and promotion, including significant experience in a senior review or governance leadership capacity.
• Demonstrated experience leading or serving as a senior decision-making member of MLR/PRC for promotional and non-promotional materials.
• Experience providing strategic, compliance-focused risk assessments and recommendations to senior cross-functional teams on promotional materials, campaigns, and activities for marketed products.
• Deep working knowledge of FDA advertising and promotion requirements, including OPDP interactions, 21 CFR 202.1, Form FDA 2253 submissions, and Subpart E experience.
• 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.
• Proven ability to translate complex regulations into practical guidance, SOPs, workflows, controls, and governance models that enable timely, compliant execution at scale.
• Strong executive presence, cross-functional influence, stakeholder management, and communication skills, with the ability to guide complex discussions and drive alignment among senior leaders.
• Demonstrated judgment and integrity, with comfort identifying and escalating compliance risks, deviations, and policy exceptions.
• Experience leading process improvement, governance, training, or inspection readiness initiatives within an advertising and promotion review function preferred.

Pay

The expected salary range for this position is $184,620–$239,700. Actual salary will be based on geographic location, experience, qualifications, and other job-related factors permitted by law.

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