The position requires at least a graduate of BS Chemistry, BS Microbiology, 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.
**Salary**: Php23,000.00 - Php25,000.00 per month
**Benefits**:
- Additional leave
- Employee discount
- Health insurance
- Opportunities for promotion
Schedule:
- 8 hour shift
Supplemental pay types:
- 13th month salary
- Overtime pay
Ability to commute/relocate:
- Marikina City: Reliably commute or planning to relocate before starting work (preferred)