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Regulatory Affairs Specialist
7 days ago
Role Description
This is a full-time role as a Regulatory Affairs Specialist at Kusum Healthcare Private Limited located in Pasig. The Regulatory Affairs Specialist will ensure compliance with regulations and standards set by regulatory authorities, developing and maintaining regulatory documentation, coordinating regulatory submissions, and providing support for regulatory inspections and audits. i.e.
Support the achievement of company goals by registering and maintaining product licenses with regulatory agencies.Provide technical assistance to relevant departments on regulatory matters such as assistance in the inclusion of products in the formulary and educating customers concerning regulatory guidelines Qualification Bachelor's degree in Pharmacy, preferably licensed PharmacistPrior experience in regulatory affairs within the pharmaceutical or healthcare industryStrong knowledge of regulatory guidelines and requirementsExcellent attention to detail and organizational skillsStrong verbal and written communication skillsAbility to work independently and collaboratively in a team environmentProficiency in Microsoft Office and regulatory databasesUnderstanding of quality management systems and good manufacturing practicesAbility to prioritize and manage multiple projects simultaneously-
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