Regulatory Pharmacist

Job Summary

The Regulatory Pharmacist ensures that the company complies with all applicable FDA regulations on licenses, product registration, internal and external audit and inspection, technical documentation and monitoring and trainings on product knowledge, pharmacovigilance, Good Storage and Distribution Practices, Current Good Manufacturing Practice, TESDA's national certification program and PRC's continuing professional development program.

III. Duties and Responsibilities

Registration

1. Prepares and submits dossiers to the regulatory authorities to support initial, renewal, amendment and compliance applications of License to Operate (LTO);

2. Prepares and submits dossiers to the regulatory authorities to support initial, renewal, amendment and compliance applications of Certificate of Product Registration (CPR);

3. Prepares documents to support the application of product promotional permits and product notifications to the regulatory authorities

4. Complies documents needed for regulatory and/orbusiness licensing compliance;

Audit / Inspection

1. Acts as a company representative and primary mover to FDA audits and inspections;

2. Acts as a company representative and co-auditor to external audits of manufacturers of company ownedproducts;

3. Prepares corrective and preventive action plans as result of discussion with concerned departments in compliance to regulatory audit findings and disseminates these action plans for proper implementation;

4. Prepares audit/inspection compliance report and submits them to FDA;

Documentation

1. Handles the monitoring of validity, recording, andfiling of regulatory documents such as License to Operate, Certificate of Product Registration, distribution contracts and quality agreements;

2. Accommodates the issuance of customer-requested regulatory documents upon validating the purpose of the request;

3. Handles the safekeeping of regulatory documents such as FDA- application dossiers, product dossiers, and contracts;

4. Prepares, submits and files records of scheduled reports of the Electronic Drug Price Monitoring System as mandated by the Department of Health (DOH-EDPMS);

5. Monitors compliance to Government Mediated Access Program (GMAP) Price Adjustment as applicable;

6. Assist the Regulatory Supervisor in preparation and submission of product labeling in compliance with the FDA requirements.

Continuous Training

1. Prepares training materials and conducts training on Product Knowledge, Pharmacovigilance, Good Distribution, andStorage Practice, Good Manufacturing Practice;

2. Acts as a facilitator in the company's training program on PRC's continuing professional development and TESDA's national certification for pharmacy services;

Dispensing

1. Oversee the retail dispensing of medicines and prepares product labels in the Pick & Pack Area prior to dispatch;

Specified Assignment

1. Pharmacist-in-Charge of DDC License to Operate as Cosmetic Wholesaler

2. Pharmacist-in-Charge of DDC License to Operate as Cosmetic Re-packer

3. Authorized Person of DDC License to Operate as Household / Urban Hazardous Substances Wholesaler

4. Regulatory Specialist in-charge of Training and Audit / Inspection particular to assigned FDA license

5. Regulatory Specialist in-charge of EDPMS and GMAP

6. Lead Pharmacist in Dispensary

Others

1. Handles the company's exercises on product quality complaint, product recall, mock recall, and traceability exercise;

2. Gives assistance to Medical Affairs Department in the creation of risk management plan for company-owned products;

3. Participates in the destruction and disposal of rejected and/orrecalled products in coordination with Returns Section;

4. Supports the Chief Pharmacist in developing programs, policies and procedures relative to the improvement of the Department and its services;

5. Abides by the company rules and regulations implemented with regards to policies and procedures, health and safety, quality management,and in the Employee's Handbook; and

6. Performs other duties that may be assigned by the Chief Pharmacist.

IV. Competencies (Knowledge, Skills, and Experience Needed for the Job)

Educational Requirements

1. Graduate Pharmacy

2. Licensed Pharmacist

Competency

1. Experience in auditing for ISO 9001

2. Experience in Quality Assurance of a Manufacturing or BPO company

Essentials

1. Ability to train employees on the product and other pharmacology related matters

2. Have distinctive Detail-oriented Skills and Planning and Organization Skills

3. Strong interpersonal and communication skills organization-wide

Desirable

1. Able to work with minimal supervision

2. Proficiency in computer skills