Regulatory Intelligence Professional

3 days ago

Varanasi, Uttar Pradesh, India beBeeRegulatory Full time US$ 60,000 - US$ 1,00,000
About Regulatory Affairs Role

As a key player in the Regulatory Intelligence team, you will be instrumental in monitoring and analyzing global regulatory trends within the life sciences industry.

You will support our regulatory intelligence offerings by actively participating in global surveillance, data acquisition, and analysis activities. You will work closely with cross-functional teams to identify emerging trends and ensure accuracy and integrity of our regulatory data.

This role is ideal for someone passionate about regulatory affairs who enjoys diving deep into complex data sets and thrives in a fast-paced environment.

Key Responsibilities
  • Monitor, acquire, track, and categorize information related to the evolving global regulatory landscape within the life sciences industry.
  • Stay up-to-date on current and relevant regulations, guidelines, policies, procedures, and practices.
  • Utilize a strong understanding of GXP to proactively identify, categorize, and analyze regulations, rules, and guidance document changes.
  • Collaborate with teams to identify and assess emerging trends in the pharmaceutical and medtech regulatory environments.
  • Conduct data quality checks to ensure accuracy, completeness, and integrity of regulatory data.
  • Monitor and report on key performance indicator (KPI) metrics related to regulatory activities.
  • Develop and implement efficient processes for data acquisition and processing while recommending improvements as 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:

  • Effective Communication: Develops clear and concise communications across multiple platforms ensuring accurate sharing of regulatory insights, updates, and trends with teams and stakeholders.
  • Decision-Making: Analyzes and evaluates regulatory data, rules, and guidance document changes to make informed decisions that drive forward regulatory intelligence activities.
  • Project Management: Organizes and prioritizes multiple projects related to monitoring, tracking, and categorizing global regulatory information while maintaining attention to detail to ensure data accuracy and relevance.
  • Continuous Learning: Demonstrates a commitment to ongoing learning by staying updated on the evolving global regulatory landscape using new insights to improve regulatory intelligence processes.
  • Technical Acumen: Leverages digital tools and technology solutions to monitor regulatory changes ensuring data accuracy and integrity.
  • Team Player: Contributes to a collaborative environment where colleagues share values and essential competencies needed to thrive in this role.

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