regulatory affairs

3 days ago

Manila, National Capital Region, Philippines Manpower Philippines Full time

Position Title: REGULATORY AFFAIRS & QA SPECIALIST

Reports To: Technical Associate- Regulatory Affairs/QA

Department/Division: Regulatory

I. JOB OBJECTIVE

(Description in specific terms of the primary goals, objectives or function of this position.)

The Regulatory Affairs & QA Specialist is responsible for assistance and support in ensuring ZPI's consistent compliance with Zoetis 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.

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

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

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

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

6. Liaise regularly and effectively with regulatory authorities in the Philippines

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

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

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

10. Manage proper documentation and closure on any Change Notification

11. Prepare artwork for ZPI 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.

2. Responsible for the finished goods release of Zoetis products before it is commercialized

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

4. 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

5. Handling Product Deviations

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

7. Assist the Global Zoetis Auditors in the conducts of Quality Systems audit of third party manufacturer and distributor

8. Prepares SOP on Quality Systems, as necessary.

9. Helps in developing raw and packaging material sourcing.

10. Manages Quality Agreement of all the contractors and suppliers of ZPI

11. 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.

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

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

4. 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.

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

III. PERFORMANCE MEASURES

  • (Critical result areas of the position and how performance will be measured)
  • Key Result Areas Measures of Performance
  • Strategic Objectives Achievement of strategic objectives in line with the business objectives
  • Personal Development Continuing education to broaden skills (both classroom and hands-on training).
  • Client Support Services Survey of internal / external client satisfaction

IV. SUPERVISORY OR MANAGERIAL RESPONSIBILITY

V. QUALIFICATIONS REQUIRED

(Description of minimum educational, work experience and other skill qualifications required for effective accomplishment of the position's objective and work responsibilities)

A. EDUCATION

Graduate of 4-year college education or higher, preferably in the Veterinary, Pharmacy or Paramedical field.

B. EXPERIENCE

Position Title or Description of Experience

At least →2 to 4 years' experience in regulatory affairs/QA work, preferably in the Pharmaceutical or veterinary industry. Affiliation and active participation in veterinary industry and government/regulatory associations

C. OTHER SKILLS

  • Good interpersonal skills
  • Decision-Making and Problem-Solving Skills
  • Good communication skills (verbal and written)
  • Proficient in Personal Computer usage
  • Have keen attention to details and quality work
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