JOB RESPONSIBILITIES:
Dossier compilation, review, submission, and follow-up with FDAUpdat
e and maintain regulatory databa
se, files, and tracking sheetsRespo
nsible for the archiving of all relevant docu
mentation in the appropriate systemSupport in the operatio
nal 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 docu
ments 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 respo
nsibilities to support the activities of the Regulatory Affairs Manager from time to time
JOB QUALIFICATIONS:
Bachelor's Degree in Pharmacy/Pharmacology or equivalentProfessio
nal License in Pharmacy is required for this positio
nAt least 1 year of working experience specializing in Regulatory Compliance or equivalent is required for this positio
nProficient in Microsoft Office and Google Suite applicatio
nsTheoretical knowledge of legislation governing medical productsUnderstand the technicality involved in regulatory submissio
nUnderstand the health product sector and how drugs are being developedExposure to Pharmacovigilance is an advantageAmenable to working in an office-ba
sed setup
AGlobal Care, Inc. emerged from roots of humble beginnings is now a leading healthcare company with a powerful combination of skills and resources that provides a platform for delivering a broad spectrum of life changing solutions. For the past decades, we continue to utilize resources to discover and develop affordable, effective, and safe products that have been manufactured with strict global quality standards.