Associate Director/Director, Regulatory, Promotional Review and Compliance
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Overview
Schedule
Full-time
Career level
Executive
Remote
Hybrid remote
Compensation
$157,080-$239,700/year
Benefits
Health Insurance
Dental Insurance
Vision Insurance
Job Description
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 OverviewThe 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.ResponsibilitiesCompliance & 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
- 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
- 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
- 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
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/
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FAQs About Associate Director/Director, Regulatory, Promotional Review and Compliance Jobs at PharmaEssentia U.
What is the work location for this position at PharmaEssentia U.?
This job at PharmaEssentia U. is located in Burlington, Massachusetts, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at PharmaEssentia U.?
Candidates can expect a pay range of $157,080 and $239,700 per year.
What employment applies to this position at PharmaEssentia U.?
PharmaEssentia U. lists this role as a Full-time position.
What experience level is required for this role at PharmaEssentia U.?
PharmaEssentia U. is looking for a candidate with "Executive" experience level.
What benefits are offered by PharmaEssentia U. for this role?
PharmaEssentia U. offers following benefits: Health Insurance, Dental Insurance, Vision Insurance, Family/Dependent Health, Paid Vacation, 401k Matching/Retirement Savings, Home Office Reimbursement/Stipend, and Health & Wellness Programs for this position. Actual benefits may vary depending on the employer's policies and employment terms.
What is the process to apply for this position at PharmaEssentia U.?
You can apply for this role at PharmaEssentia U. either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.