Consultant assisting clients in risk management within Adveez Consulting's IT department. Responsibility for system design, implementation, and compliance monitoring.
About the role
- Senior Regulatory Associate with expertise in Veeva Vault submissions and regulatory documents. Collaborating on global markets and coordinating with regulatory stakeholders.
Responsibilities
- Assists with preparation of Module 1 documents and collection of country-specific administrative forms
- Responsible for coordinating and compiling regulatory submissions
- Ensures proper archiving of submission documentation and compliance with internal SOPs
- Conducts regulatory research to identify regulatory precedents
- 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
Requirements
- Masters in pharmaceutical sciences
- Minimum around 2 years of experience in a regulatory, quality, or document management support role
- Good experience of Regulatory Submission, health authorities questions
- Experience with Veeva Vault Submissions, Registrations or other document management system
- Good Experience of Module 1
- Exposure of coordination with local regulatory affiliates and other stakeholders
- Excellent interpersonal / communication skills
- Advanced skills in Microsoft Office Applications
- Good time and project management skills
Benefits
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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