Regulatory Operations Associate

 Posted 2 hours ago
  
 Mexico
  
⭐ 2-5 years experience
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AI Summary

The associate will execute the publishing, compilation, and filing of global regulatory submissions. They are responsible for ensuring timely document submission and collaborating with cross-functional teams to maintain regulatory compliance.
Home Based - CDMX

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.


As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.


As a Regulatory Operations Associate at ICON, you will provide comprehensive regulatory operations services for clients in compliance with applicable regulations, ICON's Standard Operating Procedures, and project-specific operational alignments.


What You Will Do:

You will contribute to regulatory affairs activities, taking responsibility for your deliverables and working collaboratively.

Key responsibilities include:

  • Execute publishing, compilation, filing, and maintenance of all global regulatory submission types
  • Ensure timely and accurate submission of regulatory documents
  • Partnership with cross-functional teams to facilitate regulatory activities
  • Maintain knowledge of regulatory requirements and guidelines
  • Contribute to process improvement initiatives within the Regulatory Operations group

Your Profile:

You will bring relevant regulatory affairs experience, along with the following qualifications and skills.

Required qualifications and experience:

  • Bachelor's degree in a scientific or healthcare-related field
  • Minimum of 2 years of experience in regulatory operations within the pharmaceutical or biotechnology industry
  • Proficiency in regulatory submission software and tools
  • Strong attention to detail and organizational skills
  • Ability to work effectively in a team-oriented environment

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.


Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.


Benefits may include:

  • Competitive base salary and performance related incentives
  • Health and wellbeing programmes including medical, dental, and vision coverage where applicable
  • Retirement and pension plans
  • Life assurance and disability coverage
  • Employee assistance programmes and wellbeing resources
  • Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.


Visit our careers site to read more about the benefits ICON offers.


Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.


If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply

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