Compliance Specialist ( Fully on-site)

PharmaLink, LLC•Seminole, FL

just now•Onsite

About The Position

PharmaLink is seeking a detail-oriented Compliance Specialist to support regulatory and operational compliance activities within a pharmaceutical reverse distribution environment. This role is responsible for ensuring compliance with federal agencies and applicable state regulations governing the handling, storage, transportation, reporting, and disposition of pharmaceuticals, including controlled substances and hazardous pharmaceutical waste. The Compliance Specialist serves as a key cross-functional partner to operations, quality, controls, waste, and customer service teams to ensure regulatory requirements are met, filings are completed accurately and on time, and compliance risks are proactively identified and addressed. This role plays an important part in maintaining audit readiness, supporting inspections, improving internal processes, and promoting a culture of regulatory accountability across the organization.

Requirements

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.

Nice To Haves

Regulatory Affairs Certification (RAC) or similar
Familiarity with DSCSA (Track & Trace), reverse distribution operations, or pharmaceutical returns
Experience in multi-state compliance environments

Responsibilities

Support and help monitor compliance with applicable DEA, EPA/RCRA, FDA, and state regulatory requirements related to pharmaceutical reverse distribution operations
Partner cross-functionally with operations, quality, customer service, controls, and waste teams to support compliant handling, storage, transportation, tracking, and disposition of regulated pharmaceutical materials
Coordinate regulatory filings, reporting activities, license renewals, and compliance documentation to help ensure submissions are completed accurately and on time
Maintain compliance records, reporting calendars, and supporting documentation to promote audit readiness and regulatory compliance
Assist with internal audits, regulatory inspections, client audits, and corrective action follow-up activities
Support the development, implementation, and maintenance of SOPs, internal controls, and compliance procedures
Monitor regulatory updates and support implementation of process or policy changes as needed
Identify opportunities for process improvement, operational efficiency, and compliance risk reduction
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