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Regulatory Affairs Specialist

2 weeks ago


India beBeeRegulatoryAffairsSpecialist Full time

Job Overview: As a skilled Regulatory Intelligence Specialist, you will play a critical role in monitoring and analyzing the global regulatory landscape within the life sciences industry. You will support our regulatory intelligence products and services by actively participating in global monitoring, surveillance, and data acquisition activities.

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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.

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Responsibilities:

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  • 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.">
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Requirements:

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We are looking for a highly motivated individual with:

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  • 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.">
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Desired Skills:

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The ideal candidate should possess:

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  • Excellent communication skills to develop and deliver clear, concise communications across multiple platforms.">
  • Strong analytical and problem-solving skills to evaluate regulatory data, rules, and guidance document changes.">
  • Ability to organize and prioritize multiple time-sensitive projects related to monitoring, tracking, and categorizing global regulatory information.">
  • Commitment to continuous learning to stay updated on the evolving global regulatory landscape.">
  • Proficiency in digital tools and technology solutions to monitor regulatory changes.">
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Benefits:

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Our company offers a competitive salary and comprehensive benefits package, as well as opportunities for professional growth and development.

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Diversity and Inclusion:

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We value diversity and inclusion in our workplace and strive to create a welcoming environment for everyone.

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Keyword: RegulatoryAffairsSpecialist