Regulatory Compliance Manager

Job Description

Job Description

Company Overview

Before we opened Strive Pharmacy we were unsatisfied with the current state of the pharmaceutical industry. Most of the current pharmaceuticals only offer a one size fits all approach and often come with unwanted and potentially dangerous side effects. We found that through compounding we can offer a much more personalized solution to medicine.

Through this we have been able to help patients get the results they are seeking for their personal needs. After years of working for corporate chains we took the risk and opened Strive Pharmacy. We are dedicated to providing a better experience for each customer and clinic that we work with. Come see the Strive difference.

We're flipping the script with personal medicine. We strive to interrupt an industry that has been closed to personalized care, accessibility, and nuance for too long. We strive to shift a reactive view of self-care and ignite a proactive baseline-shifting approach to health for all. 'The human element' is our crux and catalyst, driving all that we do, whether we're interacting with patients, providers, or practices. We're here to partner with those ready for a change. More than a compounding pharmacy, we're on a mission to positively disrupt healthcare as we know it. Strive is about more than medicine. Strive is about striving for the personal side of healthcare.

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.
• Active Pharmacist license and in good standing
• Prior experience with overseeing multi-state licensure
• 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.

Annual Salary

$120,000—$140,000 USD

Benefits/ Perks

Strive Pharmacy provides a comprehensive benefits package that encompasses various perks such as employer paid healthcare coverage available after 30 days of employment, the choice of an FSA/HSA, a voucher for new hire scrubs (if applicable), parental leave, a 401(k) plan with matching contributions, and the benefit of weekends and holidays off. FREE COMPOUNDED MEDS to employees and immediate family members.

At Strive, culture plays a fundamental role in shaping our workplace atmosphere. Beyond our exceptional benefits package, we foster a sense of community. Throughout the year, we arrange various holiday potlucks and festive celebrations. Strive is committed to promoting both personal and professional development, striving for our employees to excel and grow in every aspect of their lives, both within and outside of the workplace.

Strive Pharmacy is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristics as outlined by federal, state or local laws.

Disclaimer*** Please do not call the pharmacy location with questions about your application or interview. A talent acquisition partner will reach out to you.