Regulatory Associate

D&L Industries, Inc.

Pasig

On-site

PHP 223,200 - 334,800

Full time

14 days+

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Job summary

A leading chemical manufacturing firm in Metro Manila seeks a licensed pharmacist to assist the Senior Regulatory Officer with product registrations and operational licenses. The successful candidate will prepare and file registration dossiers with the FDA, oversee licenses renewal, and ensure compliance during inspections. Ideal applicants should possess strong communication skills, good organizational abilities, and assertiveness. Full-time position based in Pasig.

Qualifications

Must be a licensed pharmacist.
Good planning and organizing skills are essential.
Experience with FDA procedures is preferred.

Responsibilities

Prepare registration dossiers and renew CPRs with the FDA.
Renew and update company License to Operate on time.
Manage FDA inspections and ensure documentation is ready.
Inform management about FDA guidelines affecting products.
Represent the company at FDA forums, seminars, and workshops.
Create a Tracking Monitoring System for licenses and CPRs.

Skills

Good planning and organizing skills

Experience dealing with the FDA

Assertive

Resourceful

Good oral and written communication skills

Pleasant personality

Education

Licensed Pharmacist

Job description

Job Summary

Assists the Senior Regulatory Officer in product registrations and securing operational licenses with various Regulatory Agencies (FDA, DENR, BAI) for the assigned Business Units or Product Categories. Uses pharmacist license for LTO and registration of Cosmetics and Personal Care products. Assists Marketing in finalizing product labels, product claims, and securing supporting documents by FDA guidelines.

Duties & Responsibilities

Prepare the registration dossier of new products and Certificate of Product Registration (CPR) renewals, file dossiers with the FDA, and ensure that certificates are released and updated.
Ensure that the company’s Licenses to Operate for all Business Units are renewed and updated on time.
Take charge during inspection visits of FDA representatives; ensure that all documents are ready and that the office and warehouse are in order.
Inform Management of any new guidelines or rulings issued by the FDA about product registrations and licenses affecting our product categories.
Represent the company in FDA forums; attend seminars and workshops required by FDA.
Establish a Tracking Monitoring System for all licenses and Certificates of Product Registration (CPR) for all CCPI products.

Qualifications