Associate Director/Director, Regulatory, Promotional Review and Compliance

About the role

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.

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
  • 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
  • Maintain monitoring of 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
  • Maintain the evolving regulatory environment and maintain current knowledge to proactively provide compliant, practical recommendations
  • 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
• 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
• Ability to maintain documentation and audit readiness for promotional materials and labeling records, including supporting inspections and audits
• Proven cross-functional influence and stakeholder management skills, with excellent written and verbal communication
• Proven judgment and integrity, with comfort identifying and escalating compliance risks, deviations, and policy exceptions

Pay

The expected salary range for this position is $157,080-$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

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

PharmaEssentia USA is 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.