What We’re Looking For
The Senior Regulatory Affairs Specialist will perform daily tasks under supervision and be responsible for coordinating and managing international shipments to ensure timely, compliant, and cost-effective importation and exportation of goods. In addition, this role will adhere to procedures to ensure compliance with state and federal regulatory agencies.
What You Will Do
- Prepare, review and submit documentation for import and export of goods.
- Facilitate regulatory clearance of import and export goods
- Track and monitor entries daily to manage clearance
- Proactively address import delays, holds, or compliance concerns
- Maintain PCCA’s relationship with its broker
- Review and approve broker invoices for accuracy including duties, storage charges and additional fees
- Maintain compliance with SOPs in a Good Manufacturing Practice (GMP) environment
- Assist in monitoring compliance plans based on state and federal regulations
- Assist in tasks required to maintain PCCA licensing with appropriate state boards and regulatory agencies
- Create and maintain work instructions supporting Regulatory Affairs processes
- Input customer orders, update customer DEA licenses, release sales orders for shipping and maintain suspicious order monitoring
- Verify inventory for controlled substances and List chemicals for all sites
- Conduct inventory reconciliation and intradepartmental audits
- Review Controlled Substance work orders and inventory records
- Assist in updating and maintaining Regulatory Affairs Standard Operating Procedures (SOPs)
- Assist with documentation of deviations and change controls
- Assist with responding to interdepartmental and external regulatory agency requests
- Generate and review regulatory documentation required for customers, manufacturers and/or products.
- Complete regulatory affairs responsibilities for item set-up, Average Wholesale Price (AWP) and National Drug Code (NDC) product data
- Complete FDA product and establishment submissions
- Update and maintain Regulatory Affairs SharePoint site and document repositories.
- Facilitate interdepartmental communication and provide information for team members in other departments related to regulatory affairs
- Complete Regulatory Affairs state reporting
- Assist with related special and interdepartmental projects, as assigned
Who You Are
- Must be detail oriented and able to work independently as well as in a team environment
- Prior experience with international cargo transportation and pharmaceutical insurance practice required
- Three years of experience in a GMP environment required
- Three years of experience in DEA and FDA regulations required
- Prior exposure to ERP and basic knowledge of supply chain flow
- Ability to use and navigate Microsoft Word, Excel, Outlook, Adobe, and SharePoint
- Must have customer service skills including one year of order entry or Customer Service experience
- Intermediate organizational, interpersonal, multi-tasking, presentation, verbal and written communication, and time management skills
- Bachelor’s Degree, a plus
Who We Are
PCCA helps pharmacists and prescribers create personalized medicine that makes a difference in patients’ lives. As a complete resource for independent compounding pharmacists, PCCA provides high-quality products, education, and support to more than 3,000 pharmacy members throughout the United States, Canada, Australia, and other countries around the world. Incorporated in 1981 by a network of pharmacists, PCCA has supported pharmacy compounding for more than 40 years. Learn more at www.pccarx.com.
