Manager, Regulatory Intelligence (India)

Apitoria Pharma; Bengaluru; Híbrido; INR 1.800.000 - 3.000.000; Jornada completa

Descripción de la vacante

Redica Systems seeks a Manager, Regulatory Intelligence to lead a global team responsible for monitoring, evaluating, and structuring regulatory developments across 150+ countries. The role ensures quality, accuracy, and timely delivery of insights across pharmaceutical, biologics, medical device, and animal health domains.

You will guide interpretation of regulatory developments, maintain data within the regulatory intelligence platform, and drive process improvements using technology and AI.

Formación

• Strong communication and stakeholder management within cross-functional teams.
• Demonstrated ability to make data-driven decisions under time pressure.
• Experience with regulatory monitoring, data classification, and GA/AI-enabled workflows.
• Knowledge of global regulatory frameworks and GxP principles.

Responsabilidades

• Lead, coach, and develop a team of Data Solutions Coordinators.
• Oversee global regulatory monitoring activities and ensure timely delivery.
• Guide assessment of regulatory developments for scope, applicability, and impact.
• Maintain standards for structured regulatory data including metadata and deadlines.
• Establish and monitor team KPIs for productivity and quality.
• Manage workload and resource allocation to ensure coverage.
• Collaborate with Product/Engineering to improve monitoring capabilities and workflows.
• Identify opportunities to apply AI/automation to regulatory operations.

Conocimientos

Communicates Effectively

Decision Quality

Optimizes Work Processes

Business Insight

Tech Savvy

Engaged

GxP Knowledge

Educación

Masters in Regulatory Affairs/Pharmaceutics/QA

Descripción del empleo

Job Description

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.