SUMMARY
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.
ESSENTIAL DUTIES AND 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 notifies the Compliance Director of any significant compliance issues and items that need to be brough to the legal team.
- Carries out other duties as assigned.
SUPERVISORY RESPONSIBILITIES:
None
QUALIFICATIONS:
EDUCATION and EXPERIENCE:
· Bachelor's degree in a relevant field (e.g., Pharmacy, Business,
Healthcare Administration, or related); advanced degree (e.g., Pharm.D.)
· Minimum 3–5 years of experience in regulatory compliance, preferably in pharmaceuticals, compounding pharmacy, healthcare marketing, or FDA-regulated advertising/promotion. Experience with 503A compounding regulations and marketing compliance strongly preferred.
· Familiarity with FDA guidance on human drug compounding (section 503A), FTC advertising rules, and related enforcement trends.
LANGUAGE SKILLS:
· Ability to read, analyze, and interpret regulatory documents, FDA guidance’s,
FTC policies, legal opinions, and technical marketing materials.
· Ability to respond to inquiries from internal teams, external partners, or regulatory agencies.
· Ability to write clear, concise compliance reports, review notes, and policy documents that conform to prescribed style and format.
· Ability to effectively communicate compliance requirements to non-expert stakeholders.
MATHEMATICAL SKILLS:
· Ability to perform basic mathematical operations such as addition, subtraction, multiplication, and division.
· Ability to apply concepts such as percentages, ratios, and proportions to practical situations (e.g., analyzing compliance metrics or audit sampling)
REASONING:
· Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
· Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
CERTIFICATES, LICENSES, REGISTRATIONS:
None required
PHYSICAL DEMANDS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee frequently is required to use computer and phone systems. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus. This fully remote position requires reliable high-speed internet and a dedicated workspace.
WORK ENVIRONMENT:
This is a fully remote position with no regular office or pharmacy site requirements. The employee works primarily in a standard home office environment with computers and phone equipment. The noise level in the work environment is usually moderate. Occasional virtual meetings or travel for training/conferences may be required.
Pay: $70,000.00 - $80,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
Work Location: Remote
