Regulatory Affairs

The Regulatory Affairs & QA Specialist is responsible for assistance and support in ensuring Company's consistent compliance with Company and Philippine government and corporate standard regulatory and QA compliance.

II. PRINCIPAL DUTIES AND RESPONSIBILITIES (Brief but specific list of the major tasks, responsibilities, major projects, decisions, etc. of this position.)

Regulatory Affairs

1.Maintains good and harmonious professional relationship with government regulatory agencies.

1. Secures the required documents and materials from Global Regulatory Affairs, other Company affiliates and local R&D needed for obtaining local registration of products for line extension, reformulations, new sourcing and shelf-life extension.

2. Maintains an organized and secure filing and retrieval system of pharmaceutical regulatory affairs documents.

3. Obtains and renews necessary Government licenses, product registrations and permits for Company to legitimately operate as importer, distributor and trader as well as exporter.

4. Ensure the most timely and optimal approvals of Company products to market with compliance to government regulations.

5. Represent the department on global and local project teams, as requested.

6. In conjunction with the Artwork Coordinator, coordination and checking of product literature, label and other packaging component in artwork preparation

7. Will also work closely with technical colleague on timely response on pharmacovigilance report and feedbacks

8. Manage proper documentation and closure on any Change Notification

9. Prepare artwork for Company's products,e.g., labels, package inserts and other commercial facsimile presentations as per BAI/FDA requirement.

Marketing Services

Provide support to marketing colleagues with regards to new products information for MAR creation and approval and registration status for estimated date of product launching.

Technical Services

Provide support to the TSMs with regards to product information and other matters to product specifications.

QA/Quality Assurance

1.Evaluation of product registration/dossier for Product Releases to ensure that regulatory commitments are being met.

1. Responsible for the finished goods release of Company products before it is commercialized

2. Assistance in handling of product complaints (includes evaluation of investigation and closure of corrective actions)

3. Provides detailed Quality Oversight to third party distributor. QA/technical support for temperature mapping and packing transport studies for cold chain products, ultra-low/freezer items and those under liquid nitrogen

4. Handling Product Deviations

5. Conducts training as necessary on implementation of quality systems.e.g PV works.

6. Assist the Global Company Auditors in the conducts of Quality Systems audit of third-party manufacturer and distributor

7. Prepares SOP on Quality Systems, as necessary.

8. Helps in developing raw and packaging material sourcing.

9. Manages Quality Agreement of all the contractors and suppliers of the Company

10. Quality oversight for stickering activities at accredited third-party manufacturer.

Organization Development

1.Develops personal performance objectives and strategies on tasks to ensure implementation and successful achievement of all plans.

1. Actively participates and contributes to the development and accomplishment of the department's objectives.

2. Formulates, together with the immediate supervisor, individual performance objectives to enhance job knowledge, technical skills and overall effectiveness on the job.

3. Promotes and enhances professional working relationship with colleagues, superiors and with FDA, BAI or other external service agencies as necessary on matters of mutual concern.

4. Performs any other duties as assigned by immediate by superior.