Associate Director, Regulatory Affairs – Oncology
Sumitomo Pharma America, Inc.
Senior Regulatory Associate – Module 1
Syneos Health
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
Senior
About the role
- 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
Requirements
- 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
Benefits
- career development and progression
- supportive and engaged line management
- technical and therapeutic area training
- peer recognition
- total rewards program
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory submission documentsinvestigational new drug applicationsnew drug applicationsdrug master filesmarketing authorisation transfersregulatory researchorphan drug designation requestscompliance with government regulationsdocument managementlifecycle maintenance activities
Soft skills
interpersonal skillscommunication skillstime managementproject management
Certifications
Masters in pharmaceutical sciences
