Senior Regulatory Affairs Specialist

What Were 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 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 PCCAs 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

Bachelors 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 3000 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 .

Required Experience:

Senior IC