• To compose routine correspondence related to products at FDA. -
• Maintain reports and also updated data related to products as well as regulatory requirements,
• Able to understand and implement the regulations governing Pharmaceutical products, Food supplements & Medical devices, -To serve as a liaison between the company and FDA,
• Shall have the ability to inter-relate and maintain good working relationships within the office at the Philippines, Head Office & FDA -Leads the development and implementation of the Organic Skin Quality Assurance and Control System
• Coordinates resolution of Quality Management issues including investigation of manufacturing or customer complaint-related concerns. -This includes reporting on KPI’s, corrective action plans, technical summaries, Management Review of Quality, on-hold inventory disposition, etc. -Ensure that established systems/procedures/protocols are adequate to provide for consistent product quality, safety, and regulatory compliance.
• Responsible for evaluation and resolution of customer/consumer product quality issues. -Provide technical support in product recalls/withdrawals. -The position is based in Speaker Perez, Banawe Quezon City -Other duties as assigned

QUALIFICATIONS:

• Candidate must possess Professional License (Passed Board / Professional Licensure Exam) in Pharmacy,
• With updated QPIRA & GMP Training Preferably with one year of work-related experience as FDA Regulatory Assistant/ Officer in a pharmaceutical company handling regulatory works and transactions with FDA as well as Head Office
• Minimum of 3 years as QA level in personal care and cosmetics or pharmaceuticals manufacturing operations. Must be capable of working in a fast-paced environment with minimal direct supervision and have strong demonstrated leadership, interpersonal, and self-initiative skills
• Strong demonstrated verbal/written communications, analytical, and problem-solving skills. -Must be detailed and results-oriented. Statistical analysis experience is preferred.
• Flexible, enthusiastic, energetic, and eager to learn and can do multi-tasking, Proficiency in Windows-based applications: Word, Excel, Access
• Good communication skills (Oral and Written) with the ability to communicate with a level of Supervisory. Job Types: Full-time, Permanent