Regulatory Affairs Specialist

6 days ago


Dublin, Dublin City, Ireland Parexel Full time
Company Overview
Parexel, a leading Clinical Research Organization (CRO), is a global partner to pharmaceutical and biotechnology companies. We deliver comprehensive solutions for managing clinical trials, regulatory submissions, and post-approval compliance.

Job Description
We are seeking a highly qualified Principal Regulatory Affairs Consultant with expertise in Chemistry, Manufacturing, and Controls (CMC) for small molecule. As a key member of our team, you will provide strategic guidance on regulatory affairs, ensuring seamless execution of projects and submission strategies.

Key Responsibilities:
• Serve as Project Leader, providing overall project leadership and ensuring successful planning and setup.
• Act as main client contact, maintaining accurate project reporting and delivering to meet client expectations.
• Develop and implement submission strategies and plans for post-approval CMC activities, including variations, renewals, market expansions, and annual reports.
• Assess change controls and provide regulatory assessments of quality changes in production and quality control.
• Review study reports from quality control and production departments to ensure compliance with regulatory requirements.

Experience and Skills Required:
• University-level education in Life Sciences or equivalent by experience.
• Extensive experience in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry.
• Strong understanding of CMC and post-approval regulatory requirements.
• Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations.
• Knowledge of small molecule processes.
• Proficient account planning and support abilities.
• Networking skills to expand professional connections.
• Team spirit, flexibility, accountability, and organizational skills.
• Strong project leadership and management knowledge.
• Strong business acumen for analysis and decision-making.
• Self-confidence and control in professional engagements.
• Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued.
• Fluency in English (written and spoken).

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