Regulatory Affairs E....
Regulatory Affairs Executive
Posted on :
05-04-2024
Employer Active
1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
05-04-2024
Job Description
Req ID : 2694392
Job Descriptions:
Prepare and review technical documents and dossiers in the format of CTD/ACTD.
Check the compliance status of the Quality Systems.
Evaluate and comment on requirements of Clinical studies.
Prepare artwork of packaging materials as per current rules and regulations.
Must have worked on ASEAN CIS and AFRICA markets.
- Review all regulatory agency submission materials for accuracy comprehensiveness or compliance with regulatory standards
- Evaluation of change controls for postapproval changes (PAC)
- Compilation review and submission of Variations
- Keeping up to date with changes in regulatory legislation and guidelines
- Description of the product and process development
- Customer queries to respond and resolve
- Maintain accurate and uptodate regulatory documentation
- Coordinate with crossfunctional teams to compile necessary documentation for submissions.
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Employment Type
Full Time
Company Industry
Key Skills
- Athletics
- Corporate Banking
- IT Management
- Facilities
- IT Support
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