Job Title: Associate Director, Advertising and Promotional Compliance, US
Location: Boston, Massachusetts, USA
Job ID: R-239426
Date Posted: 12 Nov 2025
Closing Date: 18 Nov 2025
1. Role Overview
The Associate Director, Advertising and Promotional Compliance, US, serves as the therapeutic area lead and Regulatory Affairs (RA) representative for assigned products. This role ensures compliance of promotional, non-promotional, and scientific materials with FDA regulations and internal standards. The position involves collaboration with cross-functional teams, direct communication with the FDA, and leadership in developing processes and training related to promotional compliance.
2. Key Accountabilities
Regulatory Review & Compliance
Review and approve US promotional, non-promotional, and scientific materials.
Provide real-time regulatory guidance during cross-functional review meetings.
Ensure alignment with FDA regulations related to prescription drug advertising and promotion.
FDA Interaction
Serve as primary liaison with:
Office of Prescription Drug Promotion (OPDP)
Advertising and Promotional Labeling Branch (APLB)
Handle direct communications and negotiations regarding promotional materials.
Process & Standards Development
Develop best practices, working instructions, and SOPs for advertising and promotional material creation and approval.
Ensure consistency and quality across therapeutic areas and brands.
Training & Internal Support
Deliver internal training on advertising and promotional requirements, including:
Sales training
Compliance briefings for scientific congresses
Provide subject-matter guidance for strategic product development decisions.
Regulatory Intelligence & Communication
Maintain up-to-date expertise on:
FDA enforcement actions
New regulations and industry trends
Communicate relevant updates to brand teams and senior management.
Cross-functional Collaboration
Participate in continuous improvements of promotional review processes.
Support key regulatory initiatives.
Mentor and guide colleagues within the ad/promo compliance team.
3. Essential Skills & Experience
Education
Bachelor’s degree (minimum requirement).
Experience
3+ years of experience in:
Regulatory Affairs
Advertising & Promotion within the pharmaceutical industry
Experience leading teams or managing direct reports.
Direct experience interacting with OPDP and/or APLB.
Familiarity with global advertising and promotional compliance standards.
Technical Skills
Strong understanding of US advertising/promo regulations.
Ability to assess risk and practice sound regulatory judgment.
Proficiency with:
Microsoft Office
Veeva Promomats
Veeva MedComms
Soft Skills
Excellent verbal and written communication skills.
Strong leadership, interpersonal, and collaboration skills.
Ability to influence stakeholders cross-functionally.
Knowledge of compliance requirements and industry trends.
4. Desirable/Preferred Qualifications
JD, PharmD, or Master’s degree.
5. Work Environment
Office-based role with:
Regular computer use
Phone, video, and digital communication
Problem solving, analysis, and team collaboration
Expected in-office presence: minimum 3 days per week, with flexibility.
Accommodations available for candidates with disabilities.
6. Company Culture & Values
Alexion fosters an environment built on:
Diversity and inclusion
Scientific innovation and bold thinking
Patient focus and ethical compliance
Autonomy, collaboration, and entrepreneurial spirit
Employees benefit from:
Strong leadership support
Skill and career development programs
Opportunities to impact underserved patient communities
7. Equal Opportunity Statement
Alexion is an Equal Opportunity Employer. All applicants are considered without discrimination based on protected characteristics. Reasonable accommodations are available during the application and employment process.
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