Associate Director, Regulatory Affairs – AD Promo

Job not on LinkedIn

🔥 36 minutes ago

🇺🇸 United States – Remote

💵 $200k - $221k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 20%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Praxis

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2002

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Praxis is a company dedicated to connecting patients with meaningful clinical trial opportunities. With a focus on creating customized recruitment programs, Praxis utilizes a variety of specialized tools and extensive experience across various therapeutic areas to ensure they reach the right patients worldwide. Established in 2002, the company emphasizes the importance of patient engagement and utilizes sophisticated data insights to enhance the patient journey in clinical research.

📋 Description

• Own Regulatory Affairs review and approval of advertising and promotional materials across HCP, DTC, digital, social media, sales aids, speaker materials, congress materials, and disease awareness campaigns • Ensure promotional communications are accurate, balanced, consistent with approved labeling, and compliant with FDA regulations and guidance • Partner with Commercial, Medical Affairs, and Legal to shape campaigns and claims and provide actionable guidance • Own FDA promotional submissions, including Form FDA 2253 filings • Lead Regulatory Affairs interactions with FDA OPDP, including responses to inquiries or enforcement communications • Monitor OPDP enforcement activity, evolving FDA guidance, and regulatory trends • Translate regulatory developments into implications and recommendations for Praxis teams • Build and improve scalable advertising and promotion processes, compliant records and archiving, Regulatory Operations coordination, and use of Veeva PromoMats and RIM • Partner with Regulatory Strategy on product labeling, Medical Affairs on scientific exchange and medical education, and cross-functional teams on market access, PAIE, launch readiness, and complex communications

🎯 Requirements

• Bachelor's degree in a scientific, pharmacy, health-related, or relevant discipline • 8+ years of pharmaceutical or biopharmaceutical industry experience • At least 5 years focused on regulatory advertising and promotion • Deep, current knowledge of FDA requirements and guidance governing prescription drug advertising and promotion • Experience supporting product launches, including pre-approval promotional planning and PAIE activities, strongly preferred • Experience in CNS, neurology, or rare disease preferred • Demonstrated experience with Form FDA 2253 submissions • Experience with OPDP interactions • Experience reviewing promotional materials across HCP, DTC, digital, social, and other channels • Self-directed builder who takes ownership and moves with urgency • Familiarity with Veeva PromoMats, RIM, or comparable systems preferred • Comfort with regular computer and office equipment use, screen work, basic hand coordination, clear communication, focus, and occasional movement

🏖️ Benefits

• 99% of the premium paid for medical, dental and vision plans • Company-paid life insurance • AD&D benefits • Disability benefits • Voluntary plans to personalize coverage • Dollar-for-dollar 401(k) match up to 6% on eligible contributions • Long-term stock incentives • ESPP • Discretionary quarterly bonus • Extremely flexible wellness benefit • Generous PTO • Paid holidays • Company-wide shutdowns