Manager, Regulatory Affairs – Clinical Labeling

This is a fully remote position, open to applicants in Canada.

📋 Description

• Oversee the development, revision, review, agreement, and upkeep of Investigational Medicinal Product (IMP) and Calibration Labeling.

• Collaborate with teams from Regulatory Affairs, Clinical Operations, Quality, contract research organizations, contract manufacturing organizations, translation vendors, artwork vendors, and packaging suppliers.

• Ensure that label content aligns with approved protocol requirements, product specifications, storage conditions, and country-specific regulations.

• Maintain compliance with relevant local and regional laws, regulations, GMP, GCP, company policies, EU CTR, Annex VI, EU GMP Annex 13, FDA standards, and ICH GCP guidelines.

• Offer labeling expertise during protocol formulation, initiation of clinical studies, amendments, and expansion into new countries.

• Coordinate translation efforts, multilingual labeling verification, artwork evaluation, and approval processes.

• Manage version control and the change management process for IMP documentation.

• Assist with IMP labeling submissions and notifications as needed.

• Assess new regulatory requirements and industry developments, evaluating their implications on studies.

• Provide support during regulatory inspections and audits by supplying IMP documentation and subject matter expertise.

• Act as the regulatory contact for IMP labeling, effectively resolving issues and escalating complex matters when necessary.

• Enhance labeling processes by implementing standardized templates, checklists, workflows, best practices, and tools.

• Contribute to other clinical or commercial labeling tasks and special projects as assigned.

⛳️ Requirements

• Bachelor's degree in life sciences.

• A minimum of 5 years’ experience in pharmaceutical regulatory affairs, global labeling, clinical, or clinical operations.

• At least 2 years of experience in Investigational Medicinal Product (IMP) labeling (Clinical Labeling).

• Experience in supporting IMP (clinical) labeling for clinical trials across various regions and regulatory environments.

• Familiarity with IMP lifecycle management.

• Comprehensive knowledge of relevant international, national, and regional regulatory and/or clinical frameworks, processes, and requirements.

• Strong understanding of GMP, GCP, EU CTR, Annex VI, Annex 13, and FDA IMP regulations.

• Proficiency in Microsoft Office applications and labeling management systems.

• Working knowledge of Veeva is preferred.

• Excellent communication, collaboration, adaptability, resilience, ethical conduct, and a commitment to continuous learning.

🏝️ Benefits

• Competitive salaries.

• Annual performance-based bonuses.

• Equity-based incentive program.

• Generous vacation policy.

• Paid wellness days.

• Support for professional learning and development.

• Options for hybrid and remote work arrangements within the company.