行业：Healthcare
职位：Pharmacy
部门：
人数：若干
性质：Full Time
性别：Male
婚姻：No marital status restrictions
学历： Bachelor's Degree
经验：不限
年龄：18岁以上
待遇：面议
JOB RESPONSIBILITIES:
Dossier compilation, review, submission, and follow-up with FDAUpdate and maintain regulatory database, files, and tracking sheetsResponsible for the archiving of all relevant documentation in the appropriate systemSupport in the operational and administrative preparation and submission of products for renewal and New Product Development (NPD) applications, new indications, new presentations, new manufacturing sites, and variations to FDA for drugs, and other products and follow-through from submission to approval with close supervision from RA Manager/Sr. RA PharmacistInteracts with other team members to obtain information required for submission to FDA and provide regulatory documents and information to support the businessEnsure compliance with local regulations and corporate policies and proceduresAcquire and expand knowledge of local regulations related to regulatory affairsMay assume auxiliary roles and responsibilities to support the activities of the Regulatory Affairs Manager from time to timeJOB QUALIFICATIONS:
Bachelor's Degree in Pharmacy/Pharmacology or equivalentProfessional License in Pharmacy is required for this positionAt least 1 year of working experience specializing in Regulatory Compliance or equivalent is required for this positionProficient in Microsoft Office and Google Suite applicationsTheoretical knowledge of legislation governing medical productsUnderstand the technicality involved in regulatory submissionUnderstand the health product sector and how drugs are being developedExposure to Pharmacovigilance is an advantageAmenable to working in an office-based setup