Principal Regulatory Affairs Consultant
2 miesięcy temu
This role can be home or office based in various European locations.
Key Responsibilities:
- Develop and implement submission strategies and plans for pre- and post-approval CMC activities, including MAA/BLAs 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, with ability to incorporate such report data into Module 2.3/3 .
- Coordinate CMC submission preparation with various departments, including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and CMOs .
- Write and review CMC submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities.
- 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.
- 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.
Experience and Skills Required:
- University-level education in Life Sciences or equivalent by experience.
- Extensive experience in regulatory affairs, specifically particularly related to technical/CMC/quality, within the pharmaceutical industry.
- Strong understanding of CMC and post-approval regulatory requirements.
- Experience in writing and SME reviewing CMC (technical) sections of regulatory documents such as registration files or variations.
- Knowledge of vaccines or biological 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).
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