Associate RA

Job Responsibilities

Essential Functions

• Assist with preparation of Module 1 documents and collection of country-specific administrative forms.
• Support preparation of regulatory submission documents, including components of INDs, NDAs / MAAs, DMFs, variations, renewals, MATs, and other lifecycle maintenance activities such as preparing responses to Health Authority queries and tracking commitments in compliance with current regulations and guidelines.
• Maintain and update regulatory trackers, submission timelines, and status reports.
• Ensure proper archiving of submission documentation in compliance with internal SOPs.
• Conduct regulatory research to identify precedents and support the preparation of orphan drug designation requests.
• Provide assistance to clients, customers, or other stakeholders with general regulatory information.
• Gather information through files, records, and personal contacts to prepare detailed reports and compose routine correspondence.

Qualification Requirements

Skills Required

Regulatory Submissions, Document Management, Microsoft Office, Record Management, Compliance