Regulatory Operations Expert

Há 17 horas

São Paulo, São Paulo, Brasil beBeeRegulatory Tempo inteiro R$93.750 - R$124.500
Regulatory Operations Expert

At ICON, we're seeking a skilled Regulatory Operations Expert to manage regulatory documents and processes, contributing to the successful execution of clinical trials and advancement of innovative treatments and therapies.

  • This role involves overseeing the preparation, compilation, and submission of regulatory documents for clinical trials, ensuring compliance with regulatory requirements.

The ideal candidate will have a strong understanding of regulatory operations processes and be proficient in electronic document management systems (eTMF, eCTD) and regulatory submission software.

  • Responsibilities:
    • Manage regulatory documents and processes, ensuring compliance and accessibility
    • Provide support and guidance on regulatory operations processes to internal stakeholders
    • Collaborate with cross-functional teams to ensure timely completion of regulatory deliverables

Requirements:

  • Bachelor's degree in a scientific or related field; advanced degree preferred
  • Minimum of 3 years of experience in regulatory operations within the pharmaceutical or biotech industry
  • Proficiency in electronic document management systems (eTMF, eCTD) and regulatory submission software

What We Offer:

  • Competitive salary and annual bonuses based on performance goals
  • A range of health-related benefits to employees and their families
  • Comprehensive retirement plans and life assurance
  • Flexible country-specific optional benefits, including childcare vouchers and discounted gym memberships

Our Culture:

  • We value diversity and inclusion, fostering an environment where everyone feels welcome and empowered to succeed
  • We prioritize work-life balance, providing flexible working arrangements to support our employees' well-being

How to Apply:

  • Please submit your application through our website, including your resume and cover letter

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