Compliance Analyst

AP MAX INC

4h • Remote

About The Position

The Compliance Analyst plays a critical role in supporting the company's marketing efforts for 503A compounded drugs by ensuring all promotional materials, advertising campaigns, website content, sales communications, and marketing practices fully comply with FDA regulations under section 503A of the Federal Food, Drug, and Cosmetic Act, FTC advertising standards, state pharmacy and marketing laws, and other applicable federal and state requirements as well as keeping abreast of industry trends, lawsuits, FDA 483, and regulatory issues involving our competitors. This remote position focuses on reviewing and approving marketing content, monitoring for compliance risks (such as false/misleading claims, improper promotion of compounded drugs, or implications of FDA approval/equivalence), conducting internal audits of current materials/website content, and helping maintain a culture of regulatory integrity in marketing activities. The role collaborates closely with marketing to mitigate risks while supporting business growth.

Requirements

• Experience in regulatory compliance within pharmaceuticals, compounding pharmacy, healthcare marketing, or FDA-regulated advertising/promotion environments is preferred. Familiarity with 503A compounding regulations and marketing compliance is a plus. Candidates with a combination of relevant experience, education, and transferable skills will be considered
• Familiarity with FDA guidance on human drug compounding (section 503A), FTC advertising rules, and related enforcement trends
• Bachelor’s degree in a relevant field (e.g., Regulatory Affairs, Pharmacy, Law, Business, Healthcare Administration, or related discipline), or an equivalent combination of education, training, and relevant experience. Advanced degree is preferred

Responsibilities

• Serves as a key subject matter expert on compliance requirements for marketing 503A compounded drugs, including FDA restrictions on advertising/promoting specific drugs/classes/types (per section 503A(c)), prohibitions on implying compounded products are FDA-approved or equivalent to commercial drugs, and requirements for truthful, non-misleading claims
• Reviews and approves all marketing materials (digital ads, brochures, website content, email campaigns, social media posts, sales scripts, and provider communications) for regulatory compliance before publication or distribution (Pre-Approval, In-Process Approval, and Final Approval before sending to Compliance Director for Review)
• Monitors marketing campaigns and external communications for potential violations of FDA, FTC, or state regulations, including risk areas such as unsubstantiated efficacy/safety claims, improper use of testimonials, or misleading sourcing/branding of compounded products
• Conducts regular internal compliance audits and monitoring of marketing activities, promotional practices, and third-party vendor content to identify gaps and recommend corrective actions
• Tracks and analyzes changes in relevant regulations (FDA guidance on compounding, FTC enforcement on pharmaceutical advertising, state advertising laws) and assesses their impact on marketing strategies; provides timely updates and training recommendations to marketing and sales teams
• Assists in developing, updating, and implementing compliance policies, procedures, and training programs related to marketing of compounded drugs
• Documents all reviews and approvals appropriately and ensure records are accurate and readily retrievable in the event of an audit by the Compliance Director or regulatory body and to maintain inspection readiness
• Supports investigations into potential compliance issues, complaints, or regulatory inquiries related to marketing/promotional activities, including root cause analysis and documentation of corrective/preventive actions
• Collaborates with Compliance Director, marketing leadership, and external partners (e.g., compounding pharmacies) to ensure promotional practices align with 503A exemptions and do not trigger new drug approval, misbranding, or other violations
• Promotes a culture of compliance and ethical marketing practices across remote teams
• Immediately notify the Compliance Director of any significant compliance issues and items that need to be brough to the legal team

Benefits

• Full benefits package including medical, vision, dental, 401(k) with company match, PTO, Flex days, holidays, and more!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1-10 employees