Regulatory Affairs Pharmacist

Lifestrong Marketing Inc.; Marilao; On-site; PHP 300,000 - 480,000; Full time

Job summary

Lifestrong Marketing Inc. in Marilao, Bulacan, is seeking a Regulatory Affairs professional to support the regulatory team in ensuring products comply with local requirements and industry standards.

You will prepare and submit regulatory documents and interact with FDA Philippines. The role requires willingness to work onsite in Marilao and an active pharmacist license with a Bachelor’s degree in Pharmacy, plus at least 1 year of regulatory or QA experience.

Qualifications

• Bachelor’s degree in Pharmacy and licensed Pharmacist.
• At least 1 year experience in regulatory affairs, quality assurance, or similar in PH.
• Experience with FDA Philippines regulations, product registration and approvals preferred.

Responsibilities

• Prepares and check submission of License to Operate renewals and related regulatory documents.
• Monitors licenses, permits, and FDA certificates for renewal and validity.
• Reviews SOPs and ensures documents for Cosmetic, Food, Drug and Medical Device meet FDA inspections.
• Maintains complete technical data of each product in LTO master files.
• Assists FDA inspectors and coordinates testing and product sampling timelines.
• Keeps up-to-date with regulatory changes and informs related departments.

Skills

Regulatory affairs

Quality assurance

FDA experience

Documentation

Education

Bachelor's degree in Pharmacy

Job description

Job Objective:

• Responsible for supporting the regulatory affairs team in ensuring the company’s products comply with local regulatory requirements and industry standards. This includes preparing and submitting regulatory documents, interacting with government agencies such as the Food and Drug Administration (FDA) Philippines, and ensuring that all products meet the necessary approval processes for marketing in the country.

• The position also requires the candidate to be willing to work onsite and be assigned in Marilao, Bulacan.

Job Description:

• Prepares and check submission of License to Operate renewal and other inter-related regulatory correspondence with FDA.

• Timely monitoring of product, license, permit and other licenses for renewal and ensure that all FDA license, certificates, and permits are updated and valid.

• Reviews Standard Operating Procedure based on the actual activity.

• Ensures that all pertinent documents for Cosmetic, Food, Drug and Medical Device are available for FDA inspection.

• Compiles and maintain complete technical data of each product by timely update of LTO’s master file.

• Ensures reliable IPO/Trademark monitoring

• Assists in addressing all customer inquiries by providing retention and product test results within 2 working days upon request.

• To ensure that product samples of new batches are distributed for testing 7 working days upon receipt.

• To provide product testing to Purchasing Dept. 20 working days after product test distribution or before product release to the market (for urgent testing).

OPERATIONS

• Ensures that formulation conforms to FDA standards and is within the approved limit.

• Ensures that labels of new and existing items conform to FDA Standards.

• Checking of e-Portal for newly approved CPN/CPR’s. Download, file and update the Notifications Summary.

• Generates barcode and monitoring of registration on-line.

• Ensures that Vidamed warehouses are complying with FDA requirements.

• Assists FDA inspector with the needs during inspection and makes sure that company is compliant.

• Conducts product tests for all finished goods distributed and imported by the company.

• Maintain current knowledge of relevant regulations in Cosmetic/Food/Medical device/Drugs and keeping up to date with changes in regulatory legislation and guidelines.

• Assists in updating related departments and regulatory head on latest regulatory requirements and FDA advisories.

• Coordinates the schedule of pest control.

SUPPLIERS

• Monitoring in conducting annual audits of all active suppliers.

• Coordination with manufacturers for Product Information File for filing based on ASEAN Cosmetic Directive.

• Conducts a Product Information File for filing based on ASEAN Cosmetic Directive.

• Processing of initial and renewal of agreements and request for updated GMP and ISO of all active

Qualifications:

• Bachelor’s degree in Pharmacy and licensed Pharmacist.

• At least 1 year experience in regulatory affairs, quality assurance, or a similar role within the pharmaceutical, medical device, or consumer goods industry in the Philippines.

• Experience with FDA Philippines regulations, product registration, and approval processes is strongly preferred.