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Licensing Manager

Remote · Hong Kong Full-time

Licensing Manager Position Summary Carie Boyd Pharmaceuticals, an FDA-registered 503B outsourcing facility located in Irving, Texas, is seeking a highly organized, detail-oriented, and experienced Licensing Manager to oversee the company's state and federal licensing, registration, and regulatory authorization requirements. The Licensing Manager will be responsible for maintaining the organization's licensing portfolio, ensuring timely renewals, coordinating new licensing applications, and monitoring regulatory requirements across all jurisdictions in which the company operates or distributes pharmaceutical products. This is a full-time, exempt position, and reports to the Director of Regulatory Affairs / Pharmacist In Charge. Essential Duties and Responsibilities Licensing and Regulatory Compliance

  • Manage and maintain all applicable state and federal licenses, permits, and registrations required for the company's pharmaceutical operations.
  • Oversee initial applications, renewals, amendments, and maintenance of nonresident pharmacy, outsourcing facility, manufacturer, distributor, and other applicable regulatory licenses.
  • Monitor licensing requirements across all states and jurisdictions in which the company conducts business or distributes pharmaceutical products.
  • Maintain an accurate, centralized database of licenses, registration numbers, expiration dates, renewal deadlines, fees, and associated regulatory requirements.
  • Ensure timely submission of applications and renewals to prevent licensing lapses or disruptions to business operations.
  • Coordinate required updates to licensing agencies resulting from changes in ownership, corporate structure, facility information, designated personnel, or operational activities.
  • Identify potential licensing compliance risks and proactively recommend corrective actions.

Licensing Operations and Process Improvement

  • Maintain standardized licensing procedures and internal tracking systems.
  • Maintain licensing calendars, compliance dashboards, and reporting tools.
  • Identify opportunities to streamline licensing workflows, improve efficiency, and reduce administrative risk.
  • Maintain organized electronic records of licensing applications, correspondence, approvals, and supporting documentation.
  • Prepare regular licensing status reports for management, identifying upcoming renewals, pending applications, and compliance concerns.
  • Coordinate licensing-related expenses, including application fees, renewal fees, and third-party service costs.

Business Expansion and Cross-Functional Collaboration

  • Support company expansion initiatives by determining applicable licensing prerequisites, application timelines, and regulatory restrictions.
  • Collaborate with Quality Assurance, Regulatory Affairs, Operations, Legal, and executive leadership to ensure licensing requirements align with business activities.
  • Assist leadership in evaluating regulatory changes that may impact pharmaceutical manufacturing, compounding, or distribution activities.
  • Support additional compliance and regulatory projects as assigned.

Required Qualifications

  • Bachelor's degree in Business Administration, Healthcare Administration, Regulatory Affairs, Pharmaceutical Sciences, or a related field; equivalent relevant experience may be considered.
  • Minimum of 3–5 years of experience managing licensing, registrations, or regulatory compliance within the pharmaceutical, pharmacy, healthcare, or life sciences industry.
  • Demonstrated experience with multi-state licensing and regulatory agency communications.
  • Working knowledge of state boards of pharmacy, pharmaceutical licensing requirements, and applicable federal regulations.
  • Experience preparing, submitting, and maintaining licensing applications and supporting documentation.
  • Strong organizational skills with demonstrated ability to manage multiple deadlines and competing priorities.
  • Excellent written and verbal communication skills.
  • High attention to detail, accuracy, and regulatory documentation standards.
  • Proficiency in Microsoft Office applications, including Excel, Outlook, and Word.
  • Ability to work independently and effectively in a remote environment.

Preferred Qualifications

  • Direct experience with FDA-registered 503B outsourcing facilities.
  • Experience managing licensing requirements across multiple U.S. states.
  • Familiarity with Section 503B of the Federal Food, Drug, and Cosmetic Act and applicable state outsourcing facility regulations.
  • Knowledge of interstate pharmaceutical distribution requirements.
  • Experience with FDA establishment registration processes and applicable DEA registrations.
  • Familiarity with state-specific requirements for nonresident outsourcing facilities, manufacturers, and wholesale distributors.
  • Experience with licensing management software or regulatory compliance tracking systems.
  • Prior experience developing licensing procedures, regulatory dashboards, or compliance reporting systems.

Equal Employment Opportunity Statement Carie Boyd Pharmaceuticals is an Equal Opportunity Employer. We are committed to providing equal employment opportunities to all qualified applicants and employees without regard to race, color, religion, sex, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.

Company Description

We specialize in compounding office-use and personalized prescription medications. Apply To This Job

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