Regulatory Affairs and Compliance

Hammerjack Pty Ltd; Philippines; On-site; PHP 600,000 - 800,000; Full time

Job summary

Hammerjack Pty Ltd in the Philippines seeks a regulatory affairs professional to manage licenses, permits, and registrations from initiation through renewal. You will secure required FDA documents, maintain compliant files, and ensure availability of SOPs, CPRs, LTO, and GMP certificates.

The role may involve supporting audits and regulatory activities. The ideal candidate holds a related bachelor's degree and has experience with FDA applications and product registrations.

Qualifications

• BS Pharmacy, BS Food Technology, BS Chemistry, BS Nutrition, or related course required.
• Experience in FDA application, product registration, CPR/CPN processing is an advantage.
• Strong attention to detail and knowledge of regulatory requirements.

Responsibilities

• Handle LTO, permit, certificate of registration lifecycle from initial to renewal.
• Secure and provide required FDA and regulatory documents.
• Maintain complete, orderly regulatory files and records.
• Ensure availability of SOPs, CPRs, LTO, GMPs and related certificates.
• Assist with audits and related regulatory tasks.

Skills

Regulatory compliance

Attention to detail

Documentation management

Education

BS Pharmacy

BS Food Technology

BS Chemistry

BS Nutrition

Job description

Job Description

• Handles all the activities related to relevant Licenses to Operate (LTO), permit, certificates of registration from initial, monitoring of validity, notification, renewal, filing of amendments, sales promo permit and withdrawal.
• Secures and provides the necessary documents from the FDA and other regulatory agencies as needed.
• Maintains complete and orderly files documents such as the FDA regulatory requirements, memo, Administrative Order (AO), Republic Act (RA), or management system standard.
• Ensure availability of valid regulatory documents including SOP's, CPRs, LTO, GMPs, and other related certificates.
• Perform other tasks that might be assigned from time to time such as audit

Qualification

• BS Pharmacy, BS Food Technology, BS Chemistry, BS Nutrition, or any related course.
• Experience in FDA application, product registration, CPR/CPN processing is an advantage.
• Strong attention to detail and knowledge of regulatory requirements.