Regulatory Operations Assistant II - Remote

Overview

The Regulatory Operations Assistant II is responsible for the creation, revision, compilation, and approval of specifications and documents for submission to health authorities globally, ensuring compliance with regulatory requirements.

In Short

• Prepare and review regulatory documents for product registrations.
• Create and revise raw material and packaging specifications.
• Coordinate with cross-functional teams for change control evaluations.
• Support financial data management and supplier data management.
• Assist in the creation and update of global labeling documents.
• Evaluate stability data and prepare related reports.
• Conduct literature surveys for regulatory document preparation.
• Manage document coordination with internal and external departments.
• Ensure compliance with GxP and ICH-GCP guidelines.
• Provide training and support for new associates.

Requirements

• Bachelor’s in Pharmacy or related science degree; advanced degree preferred.
• 1-2 years of experience in Regulatory Affairs or related fields.
• Technical proficiency with Microsoft Office suite.
• Good understanding of pharmaceutical product life cycle.
• Strong interpersonal and organizational skills.
• Ability to manage time effectively and focus on quality.
• Good analytical capabilities.
• Experience with Management Information Systems preferred.
• Certification in Regulatory Affairs is a plus.
• Proficiency in English and other languages is desirable.

Benefits

• Opportunity to work in a global environment.
• Engagement in a mission-driven organization.
• Supportive team culture focused on excellence.
• Career development and training opportunities.
• Flexible work environment.
• Access to a network of professionals in the field.
• Potential for advancement within the company.
• Participation in innovative projects.
• Competitive compensation package.
• Health and wellness benefits.