Senior Regulatory Affairs Associate – Global Labeling Operations

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

📋 Description

• Serve as a liaison between the Regulatory/Labeling teams and the Artwork/Change Management teams to convey scheduled artwork modifications and implementation timelines.

• Document regulatory evaluations and connect the Change Management System to the Regulatory Tracking System.

• Assist in the creation and upkeep of regulatory-compliant labeling documents throughout the product lifecycle, such as CDS, Global Patient Leaflet, Target Label Profile, EUPI, and USPI.

• Distribute and monitor CDS revisions within the Electronic Document Management System and regulatory tracking systems.

• Oversee the execution of labeling updates across various regions and countries.

• Support Regional and Local Regulatory Leads in addressing Health Authority inquiries and country-specific labeling variances.

• Ensure version control and labeling compliance within company systems.

• Develop, maintain, and revise regulatory labeling procedures and SOPs.

• Deliver training to internal stakeholders and new employees on labeling process requirements.

• Stay updated with global labeling regulations and governance standards.

⛳️ Requirements

• A minimum of 3 years of experience in the pharmaceutical or biotechnology sector, including at least 2 years in regulatory labeling operations supporting innovative medicines.

• Direct experience with products developed throughout the complete drug development and registration lifecycle within an innovator company environment.

• Understanding of applicable global regulations, pharmacology, medicine, pharmacovigilance, and drug development.

• Proven expertise with document management systems, regulatory tracking systems, and change management platforms.

• Excellent communication, organizational, and problem-solving abilities.

• Demonstrated knowledge of labeling governance and compliance.

• Proficiency in regulatory labeling operations, document management systems, and change management processes.

• Experience in pharmaceutical or biotechnology regulatory settings with an understanding of global labeling requirements.

• Bachelor's degree in a scientific or medically-related field (preferred).

• Familiarity with Structured Product Labeling (SPL) and FDA submission processes (preferred).

• Knowledge of Electronic Document Management Systems (EDMS) and regulatory tracking platforms (preferred).

• Understanding of ICH-GCP and international regulatory standards across various regions (preferred).

🏝️ Benefits

• Health, Vision & Dental Insurance

• Tuition Reimbursement

• Vacation/Holiday/Sick Time

• Flexible Spending & Health Savings Accounts

• Work/Life Balance

• 401(k) with Company match

• Pet Insurance

• Paid time off

• Life insurance

• Additional benefit offerings in accordance with applicable plans

• Certain roles may qualify for extra incentives, bonuses, or other compensation programs