Remote Regulatory Strategist – Advertising & Promotion

TechMagic with Cathy Hackl; International Falls (MN); Remote; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with Company match

Pet Insurance

Job summary

Parexel seeks a Senior Regulatory Strategist, Advertising & Promotion, to join our team in a remote capacity in the United States. You will serve as a trusted regulatory advisor supporting clinical research and commercial activities, ensuring compliance with FDA guidance and shaping product strategy.

You will work with Medical Affairs, Legal, Commercial, and Marketing to review and approve promotional materials, interpret evolving FDA guidance, and lead risk assessment discussions.

Qualifications

• 7+ years of Regulatory Affairs experience in pharma/biotech/medical devices with focus on Advertising & Promotion
• Strong knowledge of FDA regulations, guidance documents, and enforcement trends related to promotional activities
• Proven ability to advise senior stakeholders and partner with Medical Affairs, Legal, and Commercial teams
• Experience leading or facilitating regulatory review processes and committees

Responsibilities

• Provide strategic regulatory guidance on advertising and promotional materials
• Independently review and approve promotional and non-promotional content for compliance
• Interpret evolving FDA guidance and shift strategy based on enforcement trends
• Collaborate with Legal, Medical Affairs, and Commercial teams to ensure balanced communications
• Mentor junior team members and build regulatory capability across the organization
• Stay current on regulatory trends and share insights with internal stakeholders

Skills

FDA regulations

Regulatory strategy

Stakeholder management

Cross-functional collaboration

Content review/approval

Regulatory risk assessment

Job description

Parexel seeks a Senior Regulatory Strategist, Advertising & Promotion, to join our team in a remote capacity in the United States. You will serve as a trusted regulatory advisor supporting clinical research and commercial activities, ensuring compliance with FDA guidance and shaping product strategy.

You will work with Medical Affairs, Legal, Commercial, and Marketing to review and approve promotional materials, interpret evolving FDA guidance, and lead risk assessment discussions.