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 with 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.