Documentation and Regulatory Officer
4 days ago
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.
Job Type: Full-time
Pay: Php25, Php30,000.00 per month
Benefits:
- Additional leave
- Company Christmas gift
- Company events
- Employee discount
- Health insurance
- Life insurance
- Opportunities for promotion
- Paid training
- Promotion to permanent employee
- Staff meals provided
Ability to commute/relocate:
- Quezon City: Reliably commute or planning to relocate before starting work (Required)
Work Location: In person
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