Regulatory Pharmacist

8Sources Inc.; Philippines; On-site; PHP 350,000 - 600,000; Full time

Benefits offered by this job

Incentives

Quarterly gifts

HMO

Annual company trip

Retirement plan

Maternity & Paternity Leave

Sick Leave

Vacation Leave

Job summary

8Sources Inc. is seeking a Regulatory Pharmacist to ensure compliance with Philippine FDA regulations for food supplements, pharmaceuticals and manufacturing practices.

The role includes maintaining LTO and GMP certifications, managing CPR processes, and preparing regulatory submissions for new and existing products. The successful candidate will serve as the technical point of contact on regulatory matters across cosmetics, pharmaceutical, and food sectors, coordinating with internal teams and

Qualifications

• Licensed Pharmacist with PRC license.
• Knowledge of Philippine FDA regulations and product registrations.

Responsibilities

• Oversee compliance with Philippine FDA regulations for food supplements, pharmaceuticals and manufacturing practices.
• Maintain and renew License to Operate (LTO) and Good Manufacturing Practice (GMP) certifications.
• Manage Certificate of Product Registration (CPR) processes for new and existing products.
• Prepare and submit regulatory documentation in accordance with local regulations.
• Serve as technical point of contact on regulatory concerns for cosmetics, pharma, food, etc.

Skills

Regulatory affairs

Documentation

Attention to detail

Communication

Independent work

Education

Bachelor's degree

Tools

Microsoft Office

Job description

On-site - Quezon City 1-3 Yrs Exp Bachelor Full-time

Job Description

Employee Recognition and Rewards

• Incentives, Quarterly Gifts

Insurance Health & Wellness

• HMO
• Annual Company Trip, Retirement Plan
• Maternity & Paternity Leave, Sick Leave, Solo Parent Leave, Vacation Leave

The Regulatory Pharmacist is responsible for the following:

• Oversee and ensure compliance with all Philippine FDA regulations for food supplements, pharmaceuticals and manufacturing practices.
• Maintain and renew the facility's License to Operate (LTO) and Good Manufacturing Practice (GMP) certifications.
• Manage the process for Certificate of Product Registration (CPR) for new and existing products.
• Prepare and submit all necessary documentation for product registrations, renewals, and regulatory submissions in accordance with local regulations.
• Acts as technical point person on regulatory concerns, guidelines and procedures pertaining to cosmetics, pharmaceutical, food, etc., issued and carried out by FDA, DENR, Tarif Commission, etc. Implement and monitor regulatory strategies to comply with local regulatory requirements.
• Coordinate with the technical committees, making sure that SOP’s and regulatory guidelines are being followed and implemented and executed accordingly.
• Attend seminar (CCIP/FDA seminars and other seminar related to business) as necessary to be updated on the latest rules, regulations and practice.

Job requirements:

• Licensed Pharmacist with a valid PRC License
• With or without experience in Regulatory Affairs, preferably in the pharmaceutical, medical device, cosmetics, or food industry.
• Knowledge of Philippine FDA regulations and product registration processes.
• Strong attention to detail, organization, and documentation skills.
• Excellent written and verbal communication skills.
• Proficient in Microsoft Office applications.
• Able to work independently and manage multiple regulatory deadlines.

The selected applicant will be assigned to one of our affiliated companies specializing in the distribution of medical devices.

HR Officer 8Sources Inc.