Principal Regulatory Affairs Consultant - CMC Small Molecule

September 15

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Parexel

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Regulatory and product development consulting • early phase clinical research • phase II-III clinical research • late phase clinical research • eClinical solutions

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

Description

• Serve as a Project Leader, providing overall project leadership and ensuring the project's successful planning and set-up. • Act as the 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 the quality control and production departments to ensure compliance with regulatory requirements. • Coordinate submission preparation with various departments, including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies. • Write and review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities. • Collaborate within a team environment to deliver project requirements. • Prioritize workloads, both for yourself and the project team, to achieve project scope and objectives. • Deliver engaging presentations at seminars and industry group meetings. • Author articles for industry publications, demonstrating expertise and showcasing Parexel's capabilities. • Identify, escalate, and mitigate risks associated with regulatory procedures and activities. • Mentor and coach more junior members of the team. • Collaborate with Account Management to prospect and leverage new business opportunities. • Effectively communicate Parexel's service offerings, demonstrating our capability to support client needs.

Requirements

• 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. • Fluent in English (written and spoken).