Regulatory Affairs

Description

POSITION/TITLE:  Customer Technical Services & Regulatory Affairs Specialist

DEPARTMENT:  Customer Technical Services & Regulatory Affairs (CTS & RA)

REPORTS TO:  Manager CTS &RA

DUTIES/RESPONSIBILITIES:

• Responsible for handling/participating in all regulatory agency and 3^rd party cGMP and Social Compliance inspections as assigned by CTS & RA Manager
• Responsible for handling/participating in all customer cGMP audits & inspections as assigned by CTS & RA Manager
• Responsible for performing FDA facilities registration, NDC Number registration and the Canadian drug registration (DIN) as assigned by CTS & RA Manager
• Participates in the cGMP compliance program along with the QA Manager & QC Manager as assigned by the CTS & RA Manager
• Assists the QA & QC Managers with the company quality compliance program as assigned by the CTS & RA Manager
• Performs FDA food facility and Bioterrorism registrations as assigned by the CTS & RA Manager
• Participates in the process, systems, and equipment validation program as assigned by the CTS & RA Manager
• Handles the technical aspects of the Consumer Complaint Program to include reporting Adverse Events & Adverse Reactions to the proper regulatory body, i.e., US FDA, Health Canada, & Quality & Compliance (Canadian IOR)
• Participates in the Vendor & Outside Laboratory Audit Program as assigned by the CTS & RA Manager
• Participates in the Annual Internal Audit Program as assigned by the CTS & RA Manager
• Assists upper management in the compliance with all applicable regulatory requirements
• Generates international documents as required for product registration in foreign countries as assigned by the CTS & RA Manager
• Performs the review of labels for regulatory compliance & conformance with the master formula as assigned by the CTS & RA Manager
• Provides answers to Customer Service technical questions in regards to customer questions
• Participates in conducting Mock Recalls as assigned by the CTS & RA Manager
• Performs the retailer PLM programs to include writing product specifications, etc.
• Handles coordination, testing documentation, and generating the Certificate of Manufacture for all Canadian product samples returned for testing
• All other duties as assigned by management

Qualifications

• College degree desired
• Five (5)  years experience in drug product manufacturing and quality & compliance
• cGMP documentation experience desired
• Some knowledge and experience in process, systems, equipment operations and validation
• Knowledge of Microsoft Office, Excel, & J. D. Edwards
• Ability to multi-task in a fast-paced environment to assure delivery requirements
• Excellent oral and written communication skills
• Ability to keep complete and accurate records
• Ability to follow documented procedures and standards
• Excellent time management skills with the ability to work independently with little supervision

Salary : $60,000 - $80,000