COMPLIANCE SPECIALIST

Regulatory and Statutory Compliance

o Coordinates and responds to regulatory agencies regarding product information and issues.

o Prepares and submits regulatory applications, reports, materials and correspondences to identified agencies and ensures timeliness, accuracy, completeness, comprehensiveness or compliance with regulatory standards.

o Works with the Head of MSCO in developing regulatory strategies and implementation plans for the preparation and submission of new products.

o Supports the Head of MSCO in formulating, implementing and evaluating regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced accordingly.

o Maintains current knowledge of relevant regulations including proposed and final rulings.

o Assists the Head of MSCO in communicating regulatory information to relevant departments and ensures that the information is interpreted correctly.

o Provides regulatory guidance to relevant departments involved in the distribution cycle.

o Handles documentation efforts to ensure compliance with local and international regulations and standards.

o Researches emerging trends regarding industry regulations, standards and best practices to determine potential impact on organizational processes.

o Assists Food & Drug Administration (FDA) auditors in the conduct of their audit to ensure company compliance with this agency’s requirements

o Prepares and validates documents provided by the External Providers for FDA Certificate of Product Registration (CPR) and License to Operate (LTO).

o Encodes and submits FDA application thru Electronic Registration (E-Reg) and E-LTO for initial, renewal and amendment applications.

o Communicates to the FDA in cases of inquiry, clarification of standards and compliance of the company.

o Facilitates in providing the required documents for the renewal of HALAL Certificate annually.

o Assists HALAL auditors in the conduct of their annual audit and inspection to ensure company compliance with this agency’s requirements.

o Submits Bureau of Plant Industry (BPI) Import Permit upon request of the Purchasing Department.

o Submits Bureau of Animal Industry-Veterinary Quarantine Clearance (BAI-VQC) application upon request of the Purchasing Department.

o Assists BPI and BAI auditors in the renewal application of the company’s Certificate of Registration.

o Facilitates in updating the management in terms of regulatory news, changes and announcement in relation to the product and regulatory mandates.

o Attends meeting with the department’s manager for updates and other concerns, as necessary.

o Conducts pre-audit inspection to check the readiness of the plant and warehouses for actual audit of related agencies and clients.

Quality Management System

o Assists the Head of MSCO in the establishment, review, updating, cascading and implementation of MSCO policies, procedures, work instructions and forms/checklist aligned with the current ISO 9001 standard.

o Attends to all QMS related trainings, meetings and audits as needed.

o Supports the Head of MSCO on regulatory compliance and establishes the standard policies, procedures, work instructions, forms and checklists.

EDUCATION AND WORK EXPERIENCE

• Graduate of BS Engineering, BS Biology, BS Chemistry, BS Food Technology (with Professional Licensure or relevant Certifications is a plus)
• With experience on handling and processing statutory and regulatory requirements in a food manufacturing industry. With trainings and seminars on ISO 9001, Lead Auditor Course (IRCA Certified), Document Control, Food Safety, HALAL, cGWP/cGMP, Food Product Registration and Other Authorizations and Core Processes, Leadership Training