Life Sciences Regulatory Expert

1 day ago

Amrāvati, Maharashtra, India beBeeRegulatory Full time US$ 85,000 - US$ 1,10,000

Job Description

 

The Data Solutions Coordinator role is a critical position within the Regulatory Intelligence team. You will play a key part in monitoring and analyzing the global regulatory landscape within the life sciences industry.

Responsibilities include:

  • 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.
  • Maintain a thorough awareness of all 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 the accuracy, completeness, and integrity of regulatory data.
  • Monitor and report on key performance indicator (KPI) metrics related to regulatory activities.
  • Ensure that all data acquisition and processing processes are clearly defined and consistently followed, while also recommending and implementing improvements where necessary.

 

Qualifications

A minimum of 2-4 years' experience in the pharmaceutical or medical device industries, with a focus on regulatory affairs or quality assurance is required. A Master's degree in Regulatory Affairs or Quality Assurance is preferred.

 

Required Skills

The ideal candidate will possess excellent communication skills, be able to develop and deliver clear, concise communications across multiple platforms, and have the ability to analyze and evaluate regulatory data to make informed decisions.

 

Benefits

This dynamic role offers the opportunity to blend regulatory expertise with data management and process improvement in a tech-forward environment.

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