Global Labeling Project Lead – Regulatory Affairs

Apotex Corp.; Fort Lauderdale (FL); On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Disability accommodation

Job summary

Apotex Inc. is seeking a Regulatory Labeling Specialist to manage FDA-related label submissions, artwork reviews, NDC assignments, and website labeling updates.

The role ensures accurate, compliant labeling documentation across the product lifecycle and coordinates with multiple electronic systems and stakeholders. Responsibilities include reviewing US labeling issues, maintaining current regulatory knowledge, and guiding cross-functional teams through labeling changes while ensuring data

Qualifications

• Knowledge of pharmaceutical labeling regulations and regulatory submission requirements.
• Familiarity with Structured Product Labeling (SPL) processes and health authority requirements.
• Experience with document management, quality management, and regulatory information systems.
• Strong attention to detail and ability to identify labeling inconsistencies.

Responsibilities

• Review regulatory issues related to US labelling operations and advise actions.
• Keep up-to-date knowledge of regulatory requirements to ensure compliance.
• Review and approve product artworks for labeling compliance and provide feedback.
• Initiate Change Control Requests (CCR) and coordinate artwork updates in QMS.
• Assign and maintain NDC numbers and update related records.

Skills

Regulatory affairs

Pharmaceutical labeling

SPL processes

GxP compliance

Documentation management

Cross-functional teamwork

Attention to detail

Microsoft Office

Project management

Communication

Education

Bachelor's degree in Life Sciences/Regulatory Affairs/Pharmacy/Biology/ Chemistry

Tools

QMS

EDMS

Job description

Apotex Inc. is seeking a Regulatory Labeling Specialist to manage FDA-related label submissions, artwork reviews, NDC assignments, and website labeling updates.

The role ensures accurate, compliant labeling documentation across the product lifecycle and coordinates with multiple electronic systems and stakeholders. Responsibilities include reviewing US labeling issues, maintaining current regulatory knowledge, and guiding cross-functional teams through labeling changes while ensuring data