Global clinical research organization ICON plc is currently hiring a Regulatory Operations Associate to support global regulatory submission activities. This role offers an excellent opportunity for professionals with experience in regulatory operations, submission publishing, and regulatory documentation management within the pharmaceutical or biotechnology industry.
The position is part of ICON’s regulatory operations team and involves working closely with cross-functional teams to ensure accurate and timely regulatory submissions in compliance with global regulatory standards.
ICON is known globally for its expertise in clinical research, healthcare intelligence, and regulatory services, making this opportunity highly valuable for professionals seeking career growth in regulatory affairs.
Key Responsibilities
As a Regulatory Operations Associate, you will be responsible for managing regulatory submission activities and supporting regulatory compliance processes.
Primary responsibilities include:
- Execute publishing, compilation, filing, and maintenance of global regulatory submissions
- Ensure timely and accurate submission of regulatory documentation
- Coordinate with cross-functional teams to support regulatory activities
- Maintain up-to-date knowledge of global regulatory guidelines and requirements
- Support process improvements and regulatory operations initiatives
- Ensure compliance with ICON Standard Operating Procedures (SOPs) and project requirements
- Manage documentation for regulatory filings and submission records
Required Qualifications
Candidates applying for this Regulatory Operations Associate job should meet the following requirements:
- Bachelor’s degree in a scientific or healthcare-related field
- Minimum 2 years of experience in regulatory operations
- Experience working in pharmaceutical or biotechnology companies
- Familiarity with regulatory submission tools and publishing systems
- Strong attention to detail and organizational skills
- Ability to work effectively in cross-functional teams
Preferred background fields include:
- Pharmacy (B.Pharm / M.Pharm)
- Life Sciences
- Biotechnology
- Clinical Research
- Regulatory Affairs
Benefits of Working at ICON
ICON offers a competitive compensation package and a supportive work environment focused on employee well-being.
Employee benefits may include:
- Competitive salary and performance incentives
- Health insurance coverage for employees and families
- Flexible work arrangements including office or home work options
- Annual leave and paid holidays
- Retirement savings plans
- Employee assistance programs through TELUS Health
- Global career growth opportunities in the clinical research industry
Why This Regulatory Operations Job is Important
Regulatory operations professionals play a critical role in ensuring that pharmaceutical and biotech products meet regulatory requirements before reaching patients. By managing regulatory submissions and documentation, they help accelerate the drug development and approval process.
Working at ICON allows professionals to contribute to global clinical development programs, supporting therapies that improve patient outcomes worldwide.
How to Apply
