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 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 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. Responsibilities Compliance & Risk Management 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 Cross-Functional Collaboration 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 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 as applicable Establish strong partnerships and governance practices with senior internal stakeholders to enable consistent interpretation, compliant execution, and timely decision‑making Partner across Compliance & Legal to drive effective MLR/PRC governance, cross‑functional alignment, issue resolution, and well‑documented decisions Monitor evolving regulatory guidance, OPDP enforcement trends, industry practices, and relevant global considerations, and translate updates into actionable process, policy, and training enhancements Operational Excellence Provide solution‑oriented, innovative regulatory and compliance leadership that supports Company objectives while appropriately 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 across the Company and externally 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 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 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 The expected salary range for this position is $184,620-$239,700. 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. #J-18808-Ljbffr PharmaEssentia Corporation