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Regulatory Data and Systems Senior Associate - Remote

Posted 10 weeks ago
Data Analysis
Full Time
India

Overview

The Regulatory Data & Systems Senior Associate will be responsible for interpreting and executing business requirements, optimizing complex data systems, and ensuring compliance with regulatory regulations.

In Short

  • Optimize and maintain complex data models.
  • Interpret and implement regulatory requirements.
  • Assist in planning and executing departmental projects.
  • Liaise with stakeholders for timely communication.
  • Strong interpersonal and teamwork skills required.
  • 5+ years' experience as a business analyst.
  • Familiarity with GxP requirements.
  • Experience in Life Sciences, Biotech, or pharmaceutical industry.
  • Proficiency in Agile methodologies preferred.
  • Practical experience with regulatory data standards is a plus.

Requirements

  • Bachelor’s degree with 2 years of related experience.
  • Associate’s degree with 6 years of related experience.
  • High school diploma/GED with 8 years of related experience.
  • Ability to work independently with minimal direction.
  • Excellent oral and written communication skills.
  • Advanced knowledge of Veeva Vault.
  • Familiarity with global regulatory processes.
  • 5+ years’ experience in data management or related fields.

Benefits

  • Opportunity to work in a leading biotechnology company.
  • Engagement in innovative human therapeutics development.
  • Access to advanced tools and technologies.
  • Collaboration with a diverse team of professionals.
  • Focus on areas of high unmet medical need.
Amgen logo

Amgen

1074 Amgen Technology Pvt Ltd. is a leading biotechnology company dedicated to improving the quality of life for patients suffering from serious illnesses. Since its inception in 1980, Amgen has pioneered advancements in biotech, focusing on four key therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease. The company is committed to discovering, developing, manufacturing, and delivering innovative human therapeutics, leveraging advanced human genetics to address complex diseases. With a collaborative and science-based culture, Amgen strives to make a lasting impact on patients' lives while fostering an inclusive environment for its diverse workforce. As a global leader in biotechnology, Amgen continues to develop a pipeline of medicines aimed at addressing high unmet medical needs and improving health outcomes worldwide.

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