Regulatory Pharmacist (with license)AGlobal Care, Inc.

JOB DESCRIPTION
Dossier compilation, review, submission, and follow-up with FDA
Update and maintain regulatory database, files, and tracking sheets
Responsible for the archiving of all relevant documentation in the appropriate system
Support 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 drug, and other products and follow-through from submission to approval with close supervision from RA Manager/Sr. RA Pharmacist
Interacts with other team members to obtain information required for submission to FDA and provide regulatory documents and information to support the business
Ensure compliance with local regulations and corporate policies and procedures
Acquire and expand knowledge in local regulations related to regulatory affairs
May assume auxiliary roles and responsibilities to support activities of the Regulatory Affairs Manager from time to time
JOB QUALIFICATION
Bachelor's Degree in Pharmacy/Pharmacology or equivalent
Professional License in Pharmacy is required for this position
At least 1 year of working experience specializing in Regulatory Compliance or equivalent is required for this position
Proficient in Microsoft Office and Google Suite applications
Theoretical knowledge of legislation governing medical products
Understand the technicality involved in regulatory submission
Understand the health product sector and how drugs are being developed
Exposure to Pharmacovigilance is an advantage
Amenable to working in Parañaque City in an office-based setup
OTHER JOB REQUIREMENTS
Education
Bachelor's/College Degree
Field of study
Pharmacy/Pharmacology
Specialization
Pharmacy
Regulatory Compliance, Microsoft Office, Google Suite Applications, Product Knowledge, Product Registration, Keen to Details, Communication skill, Pharmacovigilance