Senior Regulatory Affairs Officer
Posted on :
11-07-2024
Employer Active
1 Vacancy
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Job Description
Responsibilities:
- Collect & Coordinate information to prepare submissions of CTD & e-CTD as per recent HA requirements (JFDA experience is an advantage)
- Review drug substance master file for compliance with specific HA & ICH guidelines.
- Contact and follow up with other departments inside and outside the company to collect documents needed for registration files
- Review all technical documents collected from other sections; CTD documents, labeling materials, specification sheets, protocols to ensure harmonized information through the submission dossier for compliance with applicable regulations.
- Responsible for the creation, compiling, hyperlinking, and formatting of documentation for dossier submissions of new products and responses to health authority using the Electronic Submission System.
- Adherence to required submission timelines and internal working practices.
Employment Type
Full Time
Company Industry
Department / Functional Area
Key Skills
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