Manager, Regulatory Affairs – Clinical Labeling

This is a fully remote position, open to applicants in United States, +4 more countries.

📋 Description

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

• Collaborate with Regulatory Affairs, Clinical Operations, Quality, Contract Research Organizations, Contract Manufacturing Organizations, translation vendors, artwork vendors, and packaging vendors.

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

• Guarantee adherence to local and regional regulations and internal policies throughout the United States, European Union, United Kingdom, Australia, Canada, Asia-Pacific, and other participating nations.

• Provide labeling expertise during protocol formulation, clinical study initiation, amendments, and country expansion efforts.

• Coordinate translation tasks and validate multilingual labeling content.

• Oversee the artwork review and approval process within the compliance system.

• Manage version control and change management processes for IMP documentation.

• Assist with IMP labeling submissions or notifications as necessary.

• Assess new regulatory updates and industry trends, determining their impact on studies.

• Support regulatory inspections and audits by providing IMP documentation and subject matter expertise.

• Act as the regulatory point of contact for IMP labeling, resolving issues independently and escalating complex matters when needed.

• Maintain streamlined labeling processes through standardized templates, checklists, and workflows.

• Identify process enhancements, best practices, and useful tools.

• Aid in other clinical or commercial labeling initiatives and special projects.

⛳️ Requirements

• Bachelor’s degree in life sciences.

• At least 5 years of experience in pharmaceutical regulatory affairs, global labeling, clinical, or clinical operations, including a minimum of 2 years in Investigational Medicinal Product (IMP) labeling (“Clinical Labeling”).

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

• Knowledge of the IMP lifecycle management process.

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

• Strong grasp of GMP, GCP, EU CTR, Annex VI, Annex 13, and FDA IMP requirements.

• Proficiency in Microsoft Office applications and labeling management systems.

• Familiarity with Veeva is preferred.

• Excellent communication, collaboration, adaptability, resilience, 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 learning and development opportunities.

• Hybrid and remote work arrangements.