Regulatory Affairs and Compliance

Greenplus Corporation; Calamba; On-site; PHP 279,000 - 502,000; Full time

Job summary

Greenplus Corporation is seeking a Regulatory Affairs professional in the Philippines to manage FDA registrations, licenses, and related regulatory documents. The role includes obtaining and renewing permits, ensuring compliance with AO/RA requirements, and maintaining organized regulatory files.

The ideal candidate holds a BS in a related field and has experience with FDA applications and CPR/CPN processing, with strong attention to regulatory details.

Qualifications

• FDA application and product registration experience is an advantage.
• Strong attention to detail and knowledge of regulatory requirements.

Responsibilities

• Handles all activities related to LTO, permits, 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

Skills

Attention to detail

Regulatory knowledge

Documentation

Education

BS Pharmacy

BS Food Technology

BS Chemistry

BS Nutrition

Related course

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.