Redica Systems
Website:
redica.com
Job details:
Redica Systems is a data and analytics SaaS platform that helps regulated industries improve their quality and stay on top of evolving regulations. We are shaping the future of predictive quality with our pioneering work in AI workflows and the development of an exclusive intelligence layer for quality and regulatory data. Our purpose-built processes transform one of the industry’s most complete data sets—aggregated from hundreds of health agencies and unique Freedom of Information Act (FOIA) sourcing—into meaningful answers and insights that reduce regulatory and compliance risk.
Founded in 2010, Redica Systems serves over 200 customers in the Pharma, BioPharma, MedTech, and Food and Cosmetics industries, including 19 of the top 20 Pharma companies and 9 of the 10 top MedTech companies. More information is available at redica.com.
The Role
Redica Systems is looking for a Manager, Regulatory Intelligence to lead a team responsible for monitoring, evaluating, and structuring regulatory developments across 150+ countries.
In this role, you will oversee the quality, accuracy, and timely delivery of regulatory intelligence covering Pharmaceutical, Biologics, MedTech, and Animal Health sectors. You'll guide the team in interpreting regulatory developments, determining industry relevance and impact, and maintaining reliable information within Redica's regulatory intelligence platform.
We're looking for a hands-on leader who brings strong GxP knowledge, sound judgment, and a practical approach to managing people, improving processes, and making effective use of technology.
Key Responsibilities
- Lead, coach, and develop a team of Data Solutions Coordinators, providing clear priorities, guidance, feedback, and performance management.
- Oversee global regulatory monitoring activities, ensuring relevant developments are identified, evaluated, and processed accurately and on time.
- Guide the team's assessment of regulatory developments, including industry scope, GxP applicability, operational impact, and classification decisions.
- Maintain standards for structured regulatory data, including metadata accuracy, effective dates, consultation deadlines, enforcement timelines, and document relationships.
- Establish and monitor team KPIs covering productivity, quality, accuracy, and turnaround times, addressing gaps and improving performance.
- Manage team workload, resource allocation, and priorities to maintain consistent regulatory coverage and meet operational objectives.
- Work with Product, Engineering, and other internal teams to improve monitoring capabilities, classification logic, quality controls, and workflows.
- Identify opportunities to use AI, automation, and other technologies to improve the efficiency, consistency, and scalability of regulatory intelligence operations.
About You
- Communicates Effectively: 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 Quality: Demonstrates the ability to make good and timely decisions in data operations. Understands the implications of various data choices.
- Optimizes Work Processes: Demonstrates the ability to enhance and streamline data processes. Seeks opportunities for data process improvement.
- Business Insight: Demonstrates an understanding of the business and uses this knowledge to inform data decisions
- Tech Savvy: Demonstrates a basic understanding of current technologies used in data operations. Can effectively use these technologies in daily work and is open to adopting new ones.
Qualifications
- 6+ years of experience in Regulatory Affairs, Quality Assurance, GxP, or Regulatory Intelligence within Pharmaceutical, Biologics, Medical Device, or Animal Health industries.
- Previous experience leading, supervising, or managing teams, with demonstrated responsibility for work quality, performance, and delivery.
- Strong understanding of GxP principles and global regulatory frameworks, including the ability to interpret regulatory language and assess industry impact.
- Experience overseeing regulatory monitoring, intelligence gathering, data classification, or compliance-related operations.
- Demonstrated ability to establish quality standards, manage operational KPIs, and improve team workflows.
- Comfortable working with technology-enabled processes, data platforms, and AI or automation tools.
- A Master's degree in Regulatory Affairs, Pharmaceutics, Quality Assurance, or a related discipline is preferred.
Additional information
Top pharmaceutical companies, food manufacturers, medtech companies, and service firms from around the globe rely on Redica Systems to mine and process government inspection, enforcement, and registration data. This enables them to quantify risk signals from their suppliers, identify market opportunities, benchmark against peers, and prepare for the latest inspection trends.
Our data and analytics have been cited by major media outlets such as MSNBC, The Wall Street Journal, and The Boston Globe.
Click on Apply to know more.
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