
Data Governance Specialist
5 days ago
We are seeking a highly skilled Regulatory Intelligence Specialist to join our dynamic team. In this role, you will play a critical part in monitoring and analyzing the global regulatory landscape within the life sciences industry.
The primary responsibility of this position is to support our regulatory intelligence products and services by actively participating in global monitoring, surveillance, and data acquisition activities. You will work closely with cross-functional teams to identify emerging trends in the pharmaceutical and MedTech regulatory environments and ensure the accuracy and integrity of our regulatory data.
Key Responsibilities:- Global Monitoring: Actively participate in global regulatory intelligence activities, including monitoring, acquiring, tracking, and categorizing information related to the evolving global regulatory landscape within the life sciences industry.
- Regulatory Awareness: Maintain a thorough awareness of all current and relevant regulations, guidelines, policies, procedures, and practices.
- Trend Identification: Utilize a strong understanding of GXP to proactively identify, categorize, and analyze regulations, rules, and guidance document changes.
- Collaboration: Collaborate with teams to identify and assess emerging trends in the pharmaceutical and medtech regulatory environments.
- Data Quality: Conduct data quality checks to ensure the accuracy, completeness, and integrity of regulatory data.
- KPI Metrics: Monitor and report on key performance indicator (KPI) metrics related to regulatory activities.
- Experience: 2-4 years of experience in the pharmaceutical or medical device industries, with a focus on regulatory affairs or quality assurance.
- Education: A Master's degree (M.S.) in Regulatory Affairs or Quality Assurance is preferred.
- Effective Communication: Develops and delivers clear, concise communications across multiple platforms, ensuring accurate and timely sharing of regulatory intelligence insights, updates, and trends with teams and stakeholders.
- Decision Making: Analyze and evaluate regulatory data, rules, and guidance document changes to make informed, timely decisions that drive forward the organization's regulatory intelligence activities.
- Project Management: Organize and prioritize multiple time-sensitive projects related to monitoring, tracking, and categorizing global regulatory information, maintaining a high level of attention to detail to ensure data accuracy and relevance.
- Continuous Learning: Demonstrate a commitment to continuous learning by staying updated on the evolving global regulatory landscape, using new insights to improve regulatory intelligence processes and outcomes.
This is an exciting opportunity for someone passionate about regulatory affairs who enjoys diving deep into data and thrives in a collaborative, fast-paced environment. If you are driven by the opportunity to make a significant impact in a high-growth company and are eager to contribute to our mission of helping companies navigate complex regulatory landscapes, we want to hear from you.
As a Regulatory Intelligence Specialist, you will have the opportunity to work with a talented team of professionals who are dedicated to creating innovative solutions for the life sciences industry. Our company offers competitive salaries, comprehensive benefits packages, and a dynamic team where you can grow and develop your skills.
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