REGULATORY PHARMACIST - #88400

Job Description

• Ensure product, LTO, and other government permits and registrations are up to date and fully compliant
• Compile registration dossiers for submission to FDA. Evaluate regulatory risk and strategy for proposed new products and ingredients. Manage, monitor and safekeeping of FDA filings
• Manage and/or participate in inspections of company facilities by FDA and other applicable agencies
• Liaise with different departments to address regulatory issues that impact compliance
• Provide regulatory input on product and packaging development
• Proof-read labels based on an understanding and interpretation of product formulas, contract provisions, account preferences and, applicable regulation policies
• Review and approve product claims intended for use in labelling and advertising, in accordance with regulatory requirements
• Bear license holder responsibility
• Participate in quality audits
• Keep the company up to date with changes in regulatory legislation and guidelines
• Provide information and training to concerned personnel with all matters relating to FDA regulations affecting product quality
• Attend to government required lectures and seminars
• Manage and/or participate in the company’s response to adverse event reports
• Other related task that may be assigned.

Job Qualifications

• Bachelors degree in Pharmacy
• Must be a licensed Pharmacist
• At least one (1) year experience in a pharmaceutical firm but fresh graduates are encouraged to apply
• Attention to detail and quality of documentation
• Good interpersonal,analytical and problem solving skills
• Effective oral and written communication skills
• Basic organizational and planning skills
• Ability to work independently with direction
• Working knowledge with FDA,PDEA, cGMP and GDP/ GSP principles is an advantage
• Knowledge of technical and quality concepts of the manufacturing and testing of pharmaceutical products
• Ability to handle multiple projects
• Good moral character
• Willing to work in Bancal, Carmona Cavite
• Working schedule will be from Mondays to Friday