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Associate Director, Advertising And Promotional Compliance, Us

3+ years
Not Disclosed
10 Nov. 17, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.