Regulatory Submissions Associate Position

Advance your career as a Regulatory Submissions Associate. This role centers on managing client submissions and providing regulatory operations support with precision.

You will build productive relationships with clients and maintain submission files within company standards. Responsibilities include the creation of compliant documents and submissions, troubleshooting issues, and leading project tasks. Your expertise in regulatory operations will significantly impact the team's success and growth.

Key Responsibilities:

• Create and format documents for client submissions

• Manage the eCTD and NeeS submission processes

• Ensure timely quality checks and feedback on submissions

• Lead initiatives for project management within the team

• Maintain records and compliance with regulatory guidelines

Requirements:

• 5–7 years of relevant experience in Regulatory Operations

• Strong computer skills in document management tools

• Excellent written and verbal communication abilities

• Comprehensive knowledge of submission types and regulations

• Capacity to manage multiple projects and deadlines

Contribute your knowledge to enhance regulatory submissions and ensure effective collaboration across teams.