Regulatory Specialist bei PharmaLink, LLC

Description

DEPARTMENT: Quality/ Regulatory Affairs

REPORTS TO: Director of Quality & Regulatory Affairs

PharmaLink 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, working cross-functionally with internal departments and external partners. The Regulatory Specialist will play a key role in maintaining compliance in daily operations, supporting audits and inspections, and promoting a culture of regulatory accountability across the organization.? 

Requirements

• 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:? 

1. DEA ARCOS reporting, biennial reporting, Form 41 records (21 CFR Part 1300–1317)? 
2. EPA hazardous waste manifests and biennial hazardous waste reports (40 CFR Subpart P (Part 266))? 
3. Florida DBPR (Chapter?499, Part I and Florida Administrative Code Chapter?61N & 64F-12)?? 
4. 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

QUALIFICATIONS:

• 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 QUALIFICATIONS:

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

PHYSICAL REQUIREMENTS:

• Prolonged periods sitting at a desk and working on a computer.? 

RELATIONSHIPS:

In performing the above responsibilities, the Regulatory Specialist of maintains the following relationships:  

• The incumbent is accountable to the Director of Quality & Regulatory Affairs, fulfilling the above responsibilities and others, which may be assigned. 
• As a service organization with a commitment to quality, it is the responsibility of each employee to maintain accurate and professional demeanor with colleagues and customers.

PharmaLink reserves the right to revise or change job duties and responsibilities as the need arises. 

Note: Please submit your request in writing to Human Resources if you wish to discuss reasonable accommodations to help you perform the essential functions of this job.?