Senior Regulatory Affairs Associate – CTA Senior Specialist

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

📋 Description

• Offer operational and regulatory assistance for CTA submissions and ongoing maintenance tasks.

• Prepare and organize global CTA and amendment documentation.

• Oversee dossier development while ensuring quality and thoroughness.

• Manage or facilitate submissions to health authorities or through local personnel.

• Act as the primary liaison for regulatory interactions.

• Collaborate with and supervise CROs for submission and query management.

• Execute the global CTA strategy.

• Ensure adherence to quality standards and compliance with country-specific requirements in regulatory submissions.

• Maintain tracking and archival systems for regulatory submissions.

• Relay EU regulatory requirements and updates to cross-functional teams.

• Contribute to enhancements in regulatory submission management processes.

⛳️ Requirements

• Bachelor's degree in Life Science or equivalent experience.

• Over 6 years of experience in the pharmaceutical industry, with at least 5 years in Regulatory Affairs.

• In-depth knowledge of EU drug development, CTR, and CTIS regulatory frameworks.

• Proven experience in CTA submission processes and regulatory compliance.

• Established leadership in EU CTA documentation and submissions.

• Comprehensive understanding of EU drug development, CTR, and CTIS workflows across various jurisdictions.

• Strong project management and leadership capabilities.

• Experience in coordinating cross-functional teams and managing vendor relationships.

• Background in clinical research, healthcare, or a regulated environment.

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

• Advanced degree in Life Science, Regulatory Affairs, or a related field is preferred.

• Familiarity with regulatory submission tracking systems and electronic document management tools is preferred.

• Knowledge of additional regulatory pathways beyond EU requirements is 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.

• Potential eligibility for additional incentives, bonuses, or other compensation programs.