Compliance and Control:

- Register our cosmetics, drugs, food supplements, medical device and household hazardous product at FDA.

- Prepare for initial or renewal of LTO licenses and coordinate with the FDA inspector

- Handle and resolve Notice of Compliance from FDA

- Maintain current knowledge of relevant regulations in Cosmetics and keeping up to date with the changes in regulatory legislation and guidelines.

- Ensures that formulation confirms to Philippine FDA standards and is within the approved limit.

- Ensures that assigned warehouses are compliant with FDA requirements.

- Conducts product test for all finished goods distributed and imported by the company.

- Schedules and facilitate monthly warehouse visit and coordinate the schedule of pest control

Customer Relations:

- Assist in updating related departments and the management on latest regulatory requirements and FDA advisories.

- Conducts product test and investigate product complaints.

- Assists in answering customer inquiries and concerns.

Suppliers:

- Assigned to handle products from imported and local suppliers.

- Conducts annual suppliers and toll manufacturer audits.

- Coordinates with manufacturers for Product Information File for filing based on ASEAN Cosmetics Directive.

- Process initial and renewal of memorandum of agreements from manufacturers.

- Request for updated GMP and ISO from manufacturers.

Requirements:

• Bachelor's degree in Pharmacy or related field.
• Experience in regulatory affairs within the pharmaceutical industry.
• Strong knowledge of FDA, EMA, and other regulatory bodies.
• Excellent written and verbal communication skills.
• Attention to detail and strong organizational skills.
• Ability to work independently and as part of a team.
• Proficiency in regulatory submission software and databases.
• Understanding of clinical trial regulations and processes.

1. Expected salary: Regulatory Manager : 40-45K

2. Work onsite : Caloocan

3. Work Monday to Friday 8:30am - 5:30pm

4. Need to know if He or She has experience in LTO inspection and release of CPR

5. Availability to Report