Data Regulatory Specialist
4 days ago
About the Job
This role is a key position in monitoring and analyzing global regulatory trends within the life sciences industry. You will support our team by actively participating in data acquisition, surveillance, and analysis 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.
This is an ideal role for someone passionate about regulatory affairs who enjoys working with data and thrives in a collaborative environment.
Responsibilities:
- 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.
- Maintain awareness of current and relevant regulations, guidelines, policies, procedures, and practices.
- Utilize understanding of GXP to proactively identify, categorize, and analyze regulations, rules, and guidance document changes.
- Collaborate with teams to identify and assess emerging trends in the pharmaceutical and medtech regulatory environments.
- Conduct data quality checks to ensure accuracy, completeness, and integrity of regulatory data.
- Monitor and report on key performance indicator (KPI) metrics related to regulatory activities.
- Ensure that all data acquisition and processing processes are clearly defined and consistently followed.
Requirements
To be successful in this role, you will need:
- 2-4 years of experience in the pharmaceutical or medical device industries with a focus on regulatory affairs or quality assurance.
- A Master's degree (M.S.) in Regulatory Affairs or Quality Assurance is preferred.
Key Skills
- Effective Communication: Develops and delivers clear communications across multiple platforms ensuring accurate sharing of regulatory insights and updates.
- Decision Making: Analyzes and evaluates regulatory data, rules, and guidance document changes to make informed decisions.
- Project Planning: Organizes and prioritizes projects related to monitoring, tracking, and categorizing global regulatory information while maintaining attention to detail.
- Continuous Learning: Stays updated on the evolving global regulatory landscape and uses new insights to improve regulatory processes and outcomes.
- Tech Savvy: Leverages digital tools and technology solutions to monitor regulatory changes ensuring data accuracy and integrity.
Benefits
We offer competitive salaries, comprehensive benefits packages, and a dynamic team where you can grow and develop your skills.
Our data and analytics have been recognized by major media outlets as a valuable resource for companies seeking to navigate complex regulatory landscapes.
We value diversity and inclusion in our workplace and strive to create an environment where everyone feels welcomed and valued.
Contact us to learn more about this exciting opportunity.
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