PharmaLink, Inc. · 5 hours ago
Regulatory Specialist ( FULLY IN-OFFICE)
Largo, FL
Full-time
Onsite
Mid Level
3+ years expPharmaLink, Inc. is seeking a detail-oriented Regulatory Specialist to support and oversee compliance activities related to DEA, FDA, EPA, and state regulations in a pharmaceutical reverse distribution environment. This role is responsible for ensuring that all regulatory requirements and filings are completed accurately and on time, while collaborating with internal departments and external partners to maintain compliance in daily operations.
LogisticsPharmaceutical
Responsibilities
Ensure company operations comply with DEA, EPA, FDA, and applicable state regulations regarding the collection, transport, and disposal of pharmaceuticals and controlled substances
Monitor internal processes and collaborate with relevant departments (e.g., operations, quality, controls, waste, customer service) to verify compliant handling, storage, transportation, and disposal of pharmaceutical products, including hazardous waste and controlled substances
Ensure all required regulatory filings and reports are completed by the appropriate internal teams or third-party providers, including: DEA ARCOS reporting, biennial reporting, Form 41 records (21 CFR Part 1300–1317), EPA hazardous waste manifests and biennial hazardous waste reports (40 CFR Subpart P (Part 266)), Florida DBPR (Chapter 499, Part I and Florida Administrative Code Chapter 61N & 64F-12), State licensing renewals and environmental submissions
Track and maintain records confirming timely completion and submission of all regulatory documentation
Act as a liaison between departments to identify and resolve compliance-related issues
Provide support and guidance to internal stakeholders on regulatory expectations and procedures
Help develop and implement SOPs and internal compliance protocols
Participate in regulatory inspections and client audits by coordinating documentation, facilitating interviews, and supporting corrective action follow-ups
Maintain audit readiness through regular internal reviews and document control
Stay informed of changes in regulatory requirements and assess their impact on company operations
Support the implementation of policy updates and process improvements as needed
Qualification
Required
Bachelor's degree in Regulatory Affairs, Life Sciences, Environmental Science, or a related field
3+ years of experience in a compliance or regulatory role in the pharmaceutical, life sciences, or healthcare distribution industry
Strong knowledge of DEA regulations for controlled substances, EPA regulations for hazardous pharmaceutical waste and reverse distribution (RCRA) and State Board of Pharmacy regulations and licensing
Knowledge of 21 CFR Part 7 (Recalls), Part 11 (Electronic Records) and Parts 210/211 (cGMP for Processing, Packing or Holding of Drugs). Knowledge of FDA requirements applicable to DSCSA
Experience supporting regulatory audits and client inspections
Excellent organizational, communication, and cross-functional collaboration skills
Ability to manage deadlines and compliance calendars effectively
Proficient in Microsoft Office 365 and compliance tracking systems
Must have a clean background and be able to pass a drug screen
Preferred
Regulatory Affairs Certification (RAC) or similar
Familiarity with DSCSA (Track & Trace), reverse distribution operations, or pharmaceutical returns
Experience in multi-state compliance environments
Company
PharmaLink, Inc.
PharmaLink, Inc. is the nation's premier Pharmaceutical Reverse Distribution provider.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
H
HILMER BECKERS
Chairman & CEO
Recent News
2024-04-28
2023-10-02
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