General Counsel

Job Overview
We are seeking an experienced and highly skilled General Counsel specializing in Healthcare and Pharmaceutical Law to serve as a key member of our legal team. The ideal candidate will provide comprehensive legal guidance on complex healthcare regulations, pharmaceutical compliance, and related legal matters. This role requires a deep understanding of various legal disciplines, including estate planning, environmental law, litigation, patent law, and more, to support our organization's strategic objectives and ensure adherence to all applicable laws and regulations. The successful candidate will demonstrate exceptional research, negotiation, and legal drafting skills within a dynamic healthcare environment.

Duties

Regulatory & Compliance Oversight

• Ensure full compliance with federal and state regulations, including FDA, DEA, DOT, OSHA, and state boards of pharmacy.
• Advise on compliance frameworks for sterile and non-sterile compounding under USP , , and .
• Develop policies, SOPs, and compliance processes across departments.
• Oversee internal audits, regulatory reporting, and risk assessments.

Litigation Management

• Manage and coordinate response to federal/state regulatory actions, investigations, or inquiries.
• Handle or oversee litigation with agencies, partners, vendors, and third parties.
• Select, supervise, and manage outside counsel as needed.

Corporate & Strategic Guidance

• Provide counsel on strategic initiatives including licensing expansion, partnerships, acquisitions, and long-term corporate structuring.
• Support due diligence for potential investments, partnerships, and the development of a future 503B outsourcing facility.
• Advise on contract negotiations, employment matters, vendor agreements, and corporate governance.

Risk Management

• Identify legal, compliance, and operational risks; build mitigation strategies.
• Establish and oversee a comprehensive enterprise risk management program.
• Advise leadership on compliance implications of business initiatives, marketing, and operational changes.

Intellectual Property

• Manage trademarks, confidentiality agreements, patents, and other IP matters.
• Protect the company's proprietary formulations, branding, digital platforms, and innovations.

Quality & Safety Collaboration

• Partner with Quality Assurance, Compliance, and Operations teams to ensure products meet regulatory, safety, and quality standards.
• Provide legal oversight on product labeling, batch testing, recalls, adverse events, and regulatory submissions.

Qualifications

• Required:
• J.D. from an accredited law school
• 8–15+ years of experience in healthcare or pharmaceutical law
• Significant experience with FDA, DEA, and state pharmacy regulation
• Strong background in compounding pharmacy, biotech, or pharmaceutical manufacturing (503A or 503B preferred)
• Experience with litigation, compliance programs, risk management, and corporate transactions

Preferred:

• Experience advising compounding pharmacies or outsourcing facilities
• Prior in-house counsel experience in a healthcare or life-sciences organization
• Experience with intellectual property management
• Strong understanding of sterile compounding quality systems and regulatory pathways
• Active U.S. bar license in good standing

Who You Are

• A strategic thinker who can operate at both the executive and operational levels
• Highly detail-oriented, analytical, and proactive
• Able to thrive in a fast-paced, rapidly scaling organization
• Skilled at communicating complex legal frameworks in simple, actionable terms
• A collaborative partner who builds strong relationships with leadership and operations teams

Pay: $250, $350,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Work Location: Hybrid remote in Tampa, FL 33647