Regulatory Compliance Manager

Position Type: Full-Time

Salary Range: $120,000 - $140,000

Position Overview:

This position involves being responsible for  implementing and managing the pharmacy’s compliance and regulatory program to ensure strict adherence to all applicable federal and state laws, regulations, and professional standards. This role is essential in safeguarding the pharmacy’s licensure, operational compliance, and reputation, with particular emphasis on sterile and non-sterile compounding practices governed by Sections 503A of the Federal Food, Drug, and Cosmetic Act. This individual will be part of a team that serves as the primary liaison with regulatory authorities, leads internal audits, oversees corrective and preventive action plans (CAPAs), and fosters a culture of continuous compliance and quality improvement throughout the organization.

Key Responsibilities:

• Serve as a key internal resource for addressing compliance-related inquiries, ensuring timely and accurate responses grounded in regulatory guidance.
• Support the development, review, and continuous improvement of standard operating procedures (SOPs) related to regulatory compliance and internal processes.
• Leverage in-depth knowledge of state and federal regulatory frameworks, with a clear understanding of how to locate and interpret applicable laws and guidelines.
• Review and vet marketing materials, including social media posts, to ensure compliance with pharmaceutical regulations such as USP 795, USP 797, and USP 800 standards.
• Collaborate with marketing teams to provide regulatory insights and ensure accurate representation of pharmaceutical products.
• Stay current with industry regulations and guidelines to advise on best practices for compliant marketing strategies.
• Work closely with legal and regulatory affairs teams to ensure alignment with overall compliance objectives.
• Provide training to marketing teams on regulatory requirements related to promotional activities.

Qualifications:

• Doctorate of Pharmacy (Pharm.D.) degree in Pharmacy, Pharmaceutical Sciences, or a closely related field.
• Proven experience in compliance and quality assurance within the pharmaceutical industry.
• In-depth knowledge of USP 795, USP 797, and USP 800 standards.
• Familiarity with FDA guidance for 503A and 503B pharmacies, including insanitary guidance.
• Strong analytical skills to assess marketing content for compliance risks.
• Excellent communication skills to effectively collaborate with other teams and convey regulatory requirements.
• Ability to adapt to evolving regulations and provide timely guidance on compliant marketing practices.
• Travel required quarterly or as needed basis.
• Comprehensive knowledge of state and federal regulatory environments, including experience navigating and applying multi-state licensing requirements.