Regulatory Pharmacist

Euro Generics International Phils. Inc.; Makati; On-site; PHP 600,000 - 900,000; Full time

Job summary

Euro Generics International Phils. Inc. seeks a licensed Pharmacist with regulatory affairs experience to support FDA submissions, renewals, and compliance across importation, distribution, and manufacturing contexts.

The role involves reviewing dossiers, ensuring labeling compliance, coordinating with FDA and suppliers, and maintaining thorough documentation for quality assurance and regulatory tracking.

Qualifications

• Bachelor's degree in pharmacy and active Pharmacist license.
• 3–5 years of regulatory affairs experience in importation, distribution or manufacturing.
• Experience in the pharmaceutical industry.
• Knowledgeable about FDA regulations.

Responsibilities

• Support regulatory activities: review new dossiers for Initial Registration and CPR renewals; handle variations and FDA submissions.
• Prepare and facilitate renewal applications for licenses and foreign GMP compliances.
• Review product dossiers and labeling/packaging to ensure FDA guideline compliance.

Skills

Regulatory affairs knowledge

Attention to detail

English proficiency

Education

Bachelor's degree in Pharmacy

Job description

QUALIFICATIONS

• Bachelor's degree in pharmacy graduate and must be a licensed Pharmacist.

• At least 3 to 5 years of experience in regulatory affairs either in importation, distribution or manufacturing industry or other relevant regulatory experience.

• Has relevant experience in pharmaceutical industry.

• Knowledgeable in FDA regulations.

• Excellent attention to detail to review reports.

• Excellent English skills in both oral and written.

RESPONSIBILITIES

• Support regulatory activities such as review of new dossier for Initial Registration, renewal of Certificate of Product Registration (CPR), handling variations, and other applications for submission to Food and Drug Administration (FDA).

• Prepares and facilitates renewal applications for all licenses and foreign Good Manufacturing Practice (GMP) compliances.

• Regularly review product dossier and labeling & packaging materials of existing products by ensuring that all information compliant with the FDA guidelines.

• Checks the status of the FDA applications regularly making sure to send follow-ups via email and other means of communication making sure there is an acknowledgment of updates for monitoring purposes.

• Ensure compliance with FDA rules & regulations and company policies and procedures.

• Regularly visit FDA office to submit applications & compliances and collect CPRs and other certificates.

• Always give updates and be in close communication with foreign suppliers, for all regulatory concerns, and documentary requirements.

• Conducts regular checking of storage & warehouse, ensuring products are stored in the correct manner and adhering to standard warehouse procedures.

• Document and supervise proper destruction and disposal of expired & damaged products.

• Conducting an internal quality inspection of incoming goods and performing random sampling, ensuring inspection is being done for final investigation for product Quality Assurance (QA), reports must be submitted to the superiors on a regular basis.

• Assisting with product queries and complaints and creating investigational reports.

• Receiving & recording of suspected Adverse Drug Reactions received from consumers, medical professionals, and clients, and ensuring proper reporting to suppliers and Marketing Authorization Holder (MAH).

• Monitor complaints and ensure that all are acknowledged in a timely manner and clients/distributors are kept informed throughout the complaint process and implement to escalat to suppliers all unresolved issues as needed.

• Support in the investigation, inspections, and implementation of Corrective Actions & Preventive Actions (CAPA).

• Handles and coordinates with FDA, manufacturers, and distributors at any time should there be any cases of serious product complaints and product recall.

• Assist supplier in the procurement of Reference List Drugs (RLD) for comparative dissolution test and bioequivalence study purposes of a drug product.

• Facilitate submission of samples to testing laboratories for assay test procedures of a product.

• May assume auxiliary roles and responsibilities to support the activities of other departments.

• Perform other duties of a similar nature or level, as assigned.