Compliance Director
ALTUS Receivables Management
Senior Regulatory Operations Associate
ICON plc
contract
Posted on:
Origin: • 🇲🇽 Mexico
Visit company websiteJob Level
Senior
Tech Stack
Vault
About the role
- Overseeing the preparation, compilation, and submission of regulatory documents for clinical trials.
- Managing electronic document management systems (eTMF, eCTD) to ensure compliance and accessibility of regulatory documents.
- Providing support and guidance on regulatory operations processes to internal stakeholders.
- Collaborating with cross-functional teams to ensure timely completion of regulatory deliverables.
- Continuously monitoring and optimizing regulatory operations processes to improve efficiency and compliance.
Requirements
- Bachelor's degree in a scientific or related field; advanced degree preferred.
- Strong knowledge with Publishing Systems: DocuBridge, Adobe Acrobat, ISI ToolBox, Liquent InSight Publisher and InSight Validator. Veeva Vault and Lorenz Validator.
- 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.
- Strong understanding of regulatory requirements and guidelines for clinical trials.
- Excellent organizational, communication, and problem-solving skills.
- Availability to work office based 3 times a week - Insurgentes / Benito Juarez
