Regulatory Intelligence Specialist

1 day ago

Vellore, Tamil Nadu, India beBeeData Full time ₹ 8,00,000 - ₹ 10,70,000
About the Role

We are seeking a skilled Data Solutions Coordinator to join our team. As a key member of our Regulatory Intelligence team, you will play a critical role in monitoring and analyzing the global regulatory landscape within the life sciences industry.

Your primary responsibility will be to support our regulatory intelligence products and services by actively participating in global monitoring, surveillance, and data acquisition activities.

You will work closely with cross-functional teams to identify emerging trends in the pharmaceutical and MedTech regulatory environments and ensure the accuracy and integrity of our regulatory data.

This is an ideal opportunity for someone passionate about regulatory affairs who enjoys diving deep into data and thrives in a collaborative, fast-paced environment.

Key Responsibilities
  1. Actively participate in global regulatory intelligence activities, including monitoring, acquiring, tracking and categorizing information related to the evolving global regulatory landscape within the life sciences industry.
  2. Maintain a thorough awareness of all current and relevant regulations, guidelines, policies, procedures, and practices.
  3. Utilize a strong understanding of GXP to proactively identify, categorize, and analyze regulations, rules, and guidance document changes.
  4. Collaborate with teams to identify and assess emerging trends in the pharmaceutical and medtech regulatory environments.
  5. Conduct data quality checks to ensure the accuracy, completeness, and integrity of regulatory data.
  6. Monitor and report on key performance indicator (KPI) metrics related to regulatory activities.
  7. Ensure that all data acquisition and processing processes are clearly defined and consistently followed, while also recommending and implementing improvements where necessary.
Qualifications
  • 2-4 years of experience in the pharmaceutical or medical device industries, with a focus on regulatory affairs or quality assurance.
  • A Master's degree (M.S.) in Regulatory Affairs or Quality Assurance is preferred.
Required Skills
  • 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: Analyze and evaluate regulatory data, rules, and guidance document changes to make informed, timely decisions that drive forward the organization's regulatory intelligence activities.
  • Plans and Aligns: Organize and prioritize multiple time-sensitive projects related to monitoring, tracking, and categorizing global regulatory information, maintaining a high level of attention to detail to ensure data accuracy and relevance.
  • Nimble Learning: Demonstrate a commitment to continuous learning by staying updated on the evolving global regulatory landscape, using new insights to improve regulatory intelligence processes and outcomes.
  • Tech Savvy: Leverage digital tools and technology solutions to monitor regulatory changes, ensuring data accuracy and integrity while contributing to the company's digital transformation and innovation in regulatory intelligence.

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