Job Description:
We are looking for a detail-oriented Regulatory affairs Specialist to be in charge of all FDA documents and activities
Responsibilities:
Processing of FDA docu
ments (LTO, Government permits and product registrations)e
valuate regulatory strategies for proposed new products and ingredientsManage inspection of company facilities by FDA and other applicable agenciesLiaise with different government offices to regulatory issues that impact compliance
Requirements:
Must be a graduate of Pharmacy/ Pharmacology or equivalentWith working knowledge with FDA, PDEA, cGMP principles is an advantageKnowledgeable of technical and quality co
ncepts of the manufacturing and testing pharmaceutical products