Regulatory Affairs Pharmacist Associate - 2 yrs Experience
Dempsey Resource Management
Date: 3 days ago
City: Caloocan City
Contract type: Full time
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.
Responsibilities
Compliance and Control:
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.
Responsibilities
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
- 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.
- 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.
- Expected salary:
- Work onsite : Caloocan
- Work Monday to Friday 8:30am - 5:30pm
- Need to know if He or She has experience in LTO inspection and release of CPR
- Availability to Report
- Preferably Female
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