Manager, Regulatory Intelligence (India)
Job Summary
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. Youll guide the team in interpreting regulatory developments determining industry relevance and impact and maintaining reliable information within Redicas regulatory intelligence platform.
Were 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 teams 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: You develop and deliver clear concise communications across multiple platforms ensuring accurate and timely sharing of regulatory intelligence insights updates and trends with teams and stakeholders.
- Decision Quality: You demonstrate the ability to make good and timely decisions in data operations. You understand the implications of various data choices.
- Optimizes Work Processes: You demonstrate the ability to enhance and streamline data processes. You seek opportunities for data process improvement.
- Business Insight: You demonstrate an understanding of the business and use this knowledge to inform data decisions.
- Tech Savvy: You demonstrate a basic understanding of current technologies used in data operations. You can effectively use these technologies in daily work and are open to adopting new ones.
- Engaged: You not only share our values but also possess the essential competencies needed to thrive at Redica as outlined here.
Qualifications :
- Familiarity with 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 Masters 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 including MSNBC The Wall Street Journal and The Boston Globe.
Remote Work :
Yes
Employment Type :
Full-time
About Company
Redica Systems is a SaaS start-up serving more than 200 customers within the life science sector, with a specific focus on Pharmaceuticals and MedTech. Our workforce is distributed globally, with headquarters in Pleasanton, CA. Redica's data analytics platform empowers companies to im ... View more