Regulatory Compliance Manager at Strive Pharmacy
Remote, Oregon, USA -
Full Time


Start Date

Immediate

Expiry Date

10 Oct, 25

Salary

140000.0

Posted On

11 Jul, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Analytical Skills, Regulatory Requirements, Regulations, Travel, Communication Skills, Pharmaceutical Industry, Pharmaceutical Sciences

Industry

Pharmaceuticals

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.

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.

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.
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.
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