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1 RPG Life Sciences Executive Regulatory Affairs Job
Sr Executive / Executive - Regulatory Affairs (API)
5-10 years
Navi Mumbai
1 vacancy
Sr Executive / Executive - Regulatory Affairs (API)
RPG Life Sciences
posted 12d ago
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Flexible timing
Key skills for the job
Job Description
JOB DESCRIPTION:
Preparation of DMF/ASMF in compliance with regulatory standards, country specific guidelines and procedures.
- Experience in handling API drug submissions to regulated markets Canada, UK, Europe, Brazil, China, Japan, US etc.
- Filing amendments, updates with relevant health agencies
- Knowledge and experience in handling submission of documentation to regulatory agency via e-CTD software
- Preparation of response to queries received from health authorities and customers
- Evaluation of regulatory impact and review of QMS documentation
- Coordination with various stake holders at site for documentation
- J articipation in project review meeting regarding new products and providing regulatory feedbackJ
Employment Type: Full Time, Permanent
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