Associate Director, Regulatory Affairs – AD Promo

This is a fully remote position, open to applicants in United States.

📋 Description

• Take charge of the Regulatory Affairs review and approval process for advertising and promotional materials across healthcare professionals (HCP), direct-to-consumer (DTC), digital platforms, social media, sales aids, speaker presentations, congress materials, and disease awareness campaigns.

• Ensure that promotional communications are precise, well-balanced, consistent with approved labeling, and in compliance with FDA regulations and guidance.

• Collaborate with Commercial, Medical Affairs, and Legal teams to shape campaigns and claims while providing actionable insights.

• Manage FDA promotional submissions, which includes Form FDA 2253 filings.

• Lead Regulatory Affairs engagements with the FDA's Office of Prescription Drug Promotion (OPDP), including responding to inquiries or enforcement communications.

• Keep track of OPDP enforcement activities, evolving FDA guidance, and regulatory trends.

• Interpret regulatory developments to provide implications and recommendations for Praxis teams.

• Develop and enhance scalable processes for advertising and promotion, maintain compliant records and archiving, coordinate Regulatory Operations, and utilize Veeva PromoMats and RIM.

• Collaborate with Regulatory Strategy on product labeling, with Medical Affairs on scientific exchange and medical education, and with cross-functional teams on market access, pre-approval promotional planning, launch readiness, and complex communications.

⛳️ Requirements

• Bachelor's degree in a scientific, pharmacy, health-related, or relevant field.

• Over 8 years of experience in the pharmaceutical or biopharmaceutical industry.

• Minimum of 5 years dedicated to regulatory advertising and promotion.

• Extensive, up-to-date knowledge of FDA requirements and guidance related to prescription drug advertising and promotion.

• Strong preference for experience in supporting product launches, including pre-approval promotional planning and post-approval integrity evaluation (PAIE) activities.

• Preferred experience in central nervous system (CNS), neurology, or rare diseases.

• Proven experience with Form FDA 2253 submissions.

• Experience interacting with OPDP.

• Expertise in reviewing promotional materials across HCP, DTC, digital, social media, and other channels.

• A self-directed individual who takes ownership and acts with urgency.

• Familiarity with Veeva PromoMats, RIM, or similar systems is preferred.

• Comfortable with regular use of computers and office equipment, screen work, basic hand coordination, effective communication, focus, and occasional movement.

🏝️ Benefits

• 99% of the premium covered for medical, dental, and vision plans.

• Company-paid life insurance.

• Accidental death and dismemberment (AD&D) benefits.

• Disability benefits.

• Voluntary plans for personalized coverage.

• Dollar-for-dollar 401(k) match up to 6% on eligible contributions.

• Long-term stock incentives.

• Employee Stock Purchase Plan (ESPP).

• Discretionary quarterly bonuses.

• Highly flexible wellness benefits.

• Generous paid time off (PTO).

• Paid holidays.

• Company-wide shutdowns.