Manager, Regulatory Intelligence

This is a fully remote position, open to applicants in India.

📋 Description

• Lead, mentor, and nurture a team of Data Solutions Coordinators.

• Provide clear priorities, guidance, feedback, and performance management.

• Oversee global regulatory monitoring activities in over 150 countries.

• Ensure timely and accurate identification, evaluation, and processing of relevant regulatory developments.

• Guide the evaluation of regulatory developments, including industry scope, GxP applicability, operational impact, and classification decisions.

• Maintain standards for structured regulatory data, focusing on metadata accuracy, effective dates, consultation deadlines, enforcement timelines, and document relationships.

• Establish and monitor team KPIs relating to productivity, quality, accuracy, and turnaround times.

• Address performance gaps and enhance team performance.

• Manage team workload, resource allocation, and priorities effectively.

• Collaborate with Product, Engineering, and other internal teams to enhance monitoring capabilities, classification logic, quality controls, and workflows.

• Identify opportunities to leverage AI, automation, and other technologies to boost efficiency, consistency, and scalability in regulatory intelligence operations.

⛳️ Requirements

• Familiarity with Regulatory Affairs, Quality Assurance, GxP, or Regulatory Intelligence in the Pharmaceutical, Biologics, Medical Device, or Animal Health sectors.

• Prior experience in leading, supervising, or managing teams, with a proven record for work quality, performance, and delivery.

• Strong grasp of GxP principles and global regulatory frameworks, with the capability to interpret regulatory language and assess its industry impact.

• Experience in overseeing regulatory monitoring, intelligence gathering, data classification, or compliance-related operations.

• Proven ability to set quality standards, manage operational KPIs, and enhance team workflows.

• Comfortable working with technology-driven processes, data platforms, and AI or automation tools.

• A Master's degree in Regulatory Affairs, Pharmaceutics, Quality Assurance, or a related field is preferred.

• Excellent communication skills across diverse platforms.

• Capacity to make sound and timely decisions in data operations.

• Ability to refine and optimize data processes.

• Understanding of business context to inform data-driven decisions.

• Basic knowledge of current technologies utilized in data operations and a willingness to adopt new technologies.

• Capability to lead, supervise, or manage teams effectively.

🏝️ Benefits

• Employees have the flexibility to work remotely.