Data Solutions Coordinator (Reg Intel) — India

Posted One Month Ago
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Hiring Remotely in Pleasanton, CA, USA
In-Office or Remote
Mid level
Information Technology • Machine Learning • Analytics
The Role
Monitors regulatory authorities across more than 150 countries, evaluates regulatory updates for industry impact, and structures intelligence data with accurate GxP tagging and metadata. Maintains regulatory framework knowledge, performs quality checks, monitors KPIs, and improves data workflows. The role requires strong regulatory judgment, analytical skills, attention to detail, and experience in pharmaceutical, biologics, medical device, or animal health regulatory affairs, quality assurance, GxP, or regulatory intelligence.
Summary Generated by Built In
Company Description

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 https://redica.com/.

Job Description

The Role

The Data Solutions Coordinator on the Regulatory Intelligence team at Redica Systems monitors global regulatory developments across 150+ countries. Responsibilities include identifying updates, assessing operational and strategic impact, determining industry scope, and ensuring accurate structured data entry in the regulatory intelligence platform. This role combines regulatory science, data structuring, and technology-enabled intelligence. Strong GxP knowledge, analytical judgment, and attention to detail are essential for this fast-paced, high-growth position.

Key Responsibilities

  • Monitor global regulatory authorities (150+ countries) to identify relevant updates impacting Pharmaceutical, Biologics, MedTech, and Animal Health sectors.

  • Evaluate regulatory developments to determine industry scope and operational or strategic impact, distinguishing actionable changes from high-volume informational updates.

  • Classify and structure regulatory intelligence within the platform, including accurate industry and GxP tagging, metadata extraction (effective dates, consultation deadlines, enforcement timelines), and linkage of related regulatory documents.

  • Maintain awareness of evolving global regulatory frameworks, identify emerging trends, and collaborate with internal teams to refine monitoring scope and classification logic.

  • Ensure data accuracy and integrity through quality checks, KPI monitoring, and continuous improvement of regulatory intelligence workflows and structured data processes.

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 the 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

  • 4 years' experience in Regulatory Affairs, Quality Assurance, GxP, or Regulatory Intelligence within Pharmaceutical, Biologics, Medical Device, or Animal Health preferred.

  • Strong understanding of GxP principles and global regulatory frameworks, with the ability to interpret regulatory language and assess practical industry impact.

  • Experience analyzing regulatory updates or compliance-related materials.

  • A Master’s degree (M.S.) in Regulatory Affairs, Pharmaceutics or Quality Assurance is preferred.

Additional Information

Top Pharma Companies, Food Manufacturers, Medical Device Companies, and Service firms from around the globe rely on Redica Systems to mine and process government inspection, enforcement, and registration data in order to quantify risk signals about their suppliers, identify market opportunities, benchmark against their peers, and prepare for the latest inspection trends. Our data and analytics have been cited by major media outlets such as MSNBC, WSJ, and the Boston Globe. 

Redica Systems is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where everyone feels welcomed and valued. We believe that diversity of perspectives, backgrounds, and experiences is essential to our success. We are always looking for talented individuals who can bring unique skills and perspectives to our team. All your information will be kept confidential according to EEO guidelines.

 

Skills Required

  • Four years of experience in Regulatory Affairs, Quality Assurance, GxP, or Regulatory Intelligence within Pharmaceutical, Biologics, Medical Device, or Animal Health industries
  • Strong understanding of GxP principles and global regulatory frameworks
  • Ability to interpret regulatory language and assess practical industry impact
  • Experience analyzing regulatory updates or compliance-related materials
  • Master’s degree in Regulatory Affairs, Pharmaceutics, or Quality Assurance
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The Company
HQ: Pleasanton, CA
89 Employees
Year Founded: 2010

What We Do

Redica Systems is a data analytics platform to help regulated industries improve their quality and stay on top of evolving regulations. Our proprietary 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. With human expertise, machine learning, and automation, we assimilate, normalize, and organize large amounts of unstructured data to make sure all entities are represented and connected. The RedicaID provides a real-time view into evolving data by tracking inspections, enforcement actions, regulatory publications, and M&A activity. In a complex landscape that’s always in flux, the RedicaID is a reliable constant. Founded in 2010, Redica Systems serves over 200 customers in the pharma, biopharma, medtech, medical device, and food and cosmetics industries, including 19 of the top 20 pharma companies and 9 of the 10 top medical devices companies. The FDAzilla store is a wholly-owned subsidiary of Redica Systems. Redica Systems’ headquarters are in Pleasanton, CA. More information is available at www.redica.com.

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