Regulatory & Compliance Associate

Private Advertiser; Batangas City; On-site; PHP 300,000 - 500,000; Full time

Job summary

Private Advertiser is seeking a qualified regulatory specialist who will represent the company with government bodies, ensure FDA registration readiness, and guide product development through regulatory compliance. The role requires deep knowledge of development, research, manufacturing practice, and approval processes.

The successful candidate will collaborate with project teams on export and labeling requirements, interpret guidelines, and communicate regulations clearly to inform company

Qualifications

• Licensed Pharmacist, Chemical Engineer, or Chemical Technician.
• Relevant years of related work experience.
• Proficient in oral & written communication.
• Computer Literate.

Responsibilities

• Representing the company in complying with the requirements of the government regulating bodies on products and facilities, except for local permits.
• Check the necessary documents, including the Product Information File (PIF), as required for FDA product registration.
• Must understand all aspects of product development, including research, clinical trials/tests, manufacturing practice, regulations, and approval process.
• Participating with project teams on the regulatory requirements for export, labelling requirements, or clinical study compliance.
• Provide and explain regulations to determine the impact on company activities.
• Identify and interpret regulatory guidelines

Skills

Oral & written communication

Computer literacy

Education

Licensed Pharmacist

Chemical Engineer

Chemical Technician

Job description

DUTIES AND RESPONSIBILITIES:

• Representing the company in complying with the requirements of the government regulating bodies on products and facilities, except for local permits.
• Check the necessary documents, including the Product Information File (PIF), as required for FDA product registration.
• Must understand all aspects of product development, including research, clinical trials/tests, manufacturing practice, regulations, and approval process.
• Participating with project teams on the regulatory requirements for export, labelling requirements, or clinical study compliance.
• Provide and explain regulations to determine the impact on company activities.
• Identify and interpret regulatory guidelines

QUALIFICATION AND EDUCATION REQUIREMENTS:

• Licensed Pharmacist, Chemical Engineer, or Chemical Technician
• Relevant years of related work experience
• Proficient in oral & written communication
• Computer Literate