Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.
Post : Senior Regulatory Associate (Module 1)
Job Description
• Assists with preparation of Module 1 documents and collection of country-specific administrative forms..
• Assists with preparation of regulatory submission documents including components of investigational new drug applications (INDs), new drug applications or new marketing applications (NDAs/MAAs), drug master files (DMFs), variations, renewals, marketing authorisation transfers (MATs) and other lifecycle maintenance activities - preparing responses to Health Authority queries and tracking HA commitments etc., according to current government regulations and guidelines.
• Maintains and updates regulatory trackers, submission timelines, and status reports.
• Ensures proper archiving of submission documentation and compliance with internal SOPs
• Conducts regulatory research to identify regulatory precedents and to support the preparation of orphan drug designation requests.
• Assists clients, customers, or others with general information
• Gathers information, searches files and records, and makes personal contacts to obtain specific information in order to prepare detailed reports and compose routine correspondence.
Candidate Profile
• Masters in pharmaceutical sciences.
• Minimum around 4 years of experience in a regulatory, quality, or document management support role. Excellent interpersonal / communication skills.
• Advanced skills in Microsoft Office Applications.
• Good time and project management skills, preferred.
Additional Information
Experience : 4 years
Qualification : M.Pharm
Location : IND-Remote
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 30th October 2025
Apply here for Regulatory Associate
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