Regulatory Pharmacist

Job description
The position requires at least a graduate of BS Pharmacy or any other related course. He/she must have a good understanding of the interactions between the company's various regulatory and GMP requirements. He/she must be able to manage his/her time and projects in order to meet deadlines while complying the quality objectives. An excellent data management skill is necessary, as well as a first-rate communication efficiency.
Job Summary:
The Documentation and Regulatory Officer is responsible for maintaining the Company's Archives. He/she prepares, issues and keeps all manufacturing process documents. Documenting complaints and recalls is also his/her responsibility. He/she is also responsible for product registrations, license renewals, periodic updates, and registrations to regulatory agencies.
Duties and Responsibilities:
• Prompt issuance of manufacturing records and forms to insures smooth flow of production schedules.
• Advise departments on document management process.
• Verify that documents conform to the company standards prior to release.
• Receive and process documents from all departments.
• Register, index and classify documents in the document management system.
• Record, publish and notify as to the availability and update of all documentation.
• Participate in establishing procedures, guidelines and forms.
• Collect and coordinate information and prepare regulatory documentations for submission to regulatory agencies or to commercial partners.
• Advise on the regulatory agency submission strategy.
• Timely compile materials for license renewals, updates and registrations.
• Maintain regulatory files/database and chronologies in good order.
• Establish and maintain system for tracking changes in documents submitted to agencies or partners.
• Review (proof) labeling and label for compliance with regulatory requirements.
• Maintain knowledge of FDA, BAI, PDEA, etc. and international regulation, guidance and standards applicable to company products.