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

• Education: A Master's degree in Pharmaceutical Sciences.
• Experience: A minimum of approximately 2 years of experience in a regulatory, quality, or document management support role.
• Skills:
• Excellent interpersonal and communication skills.
• Advanced proficiency in Microsoft Office Applications.
• Good time and project management skills are preferred.