Associate RA ( Module 1, regulatory submission)

We are seeking an Associate RA (Regulatory Affairs) professional to assist with the preparation and submission of crucial regulatory documents. This role primarily focuses on Module 1 documents and various lifecycle maintenance activities, ensuring compliance with global regulations. The ideal candidate will have a master's degree in pharmaceutical sciences and experience in a regulatory support role, demonstrating excellent communication and organizational skills.

Essential Functions

• Regulatory Document Preparation :
• Assist with the preparation of Module 1 documents and the collection of country-specific administrative forms.
• Aid in preparing various regulatory submission documents , including components of investigational new drug applications (INDs), new drug applications / marketing authorization applications (NDAs / MAAs), drug master files (DMFs), variations, renewals, and marketing authorization transfers (MATs).
• Prepare responses to Health Authority queries and track Health Authority commitments.
• Tracking and Archiving :
• Maintain and update regulatory trackers , submission timelines, and status reports.
• Ensure proper archiving of submission documentation and compliance with internal SOPs.
• Regulatory Research & Support :
• Conduct regulatory research to identify precedents and support the preparation of orphan drug designation requests.
• Assist clients and customers with general information requests.
• Gather information from files, records, and contacts to prepare detailed reports and routine correspondence.

Qualification Requirements

Skills Required

regulatory documentation, Research Analysis, Communication Skills, Project Management, Microsoft Office Applications, pharmaceutical industry