Regulatory Affairs Specialist

Dempsey Resource Management Inc.; Quezon City; On-site; PHP 391,000 - 781,000; Full time

Job summary

Dempsey Resource Management Inc. in Makati City seeks a Regulatory Affairs professional to support legal and registration activities for FDA dossiers.

You will prepare, compile, and submit high-quality registration dossiers to the FDA, ensure compliance with regulatory mandates, and act as the liaison between the company and government agencies.

Bachelor's in Pharmacy or Life Sciences, 1–2 years regulatory affairs experience, and willing to conduct field work.

Qualifications

• Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or Life Sciences.
• 1–2 years of regulatory affairs experience.
• FDA registrations for medical devices and pharmaceuticals preferred.

Responsibilities

• Provide comprehensive technical assistance for regulatory affairs activities.
• Prepare, compile, and submit registration dossiers to the FDA.
• Ensure products and documentation comply with regulatory mandates.
• Act as liaison between the company and government regulatory bodies.

Skills

Regulatory affairs experience

Education

Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or Life Sciences

Job description

KEY RESPONSIBILITIES

• 1. Technical Support: Provide comprehensive technical assistance for the legal and registration activities of the Regulatory Affairs Department


• 2. FDA Registration: Prepare, compile, and submit high-quality registration dossiers to the Food and Drug Administration (FDA)


• 3. Compliance Monitoring: Ensure all products, documentations, and corporate operations strictly comply with current mandates from specific regulatory agencies


• 4. Liaison Functions: Act as a reliable point of contact between the company and government regulatory bodies

QUALIFICATIONS

• - Education: Graduate of Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or any Life Sciences course


• - Experience: Minimum 1 to 2 years of solid working experience in a regulatory affairs role


• - Domain Advantage: Prior experience in handling FDA registrations for BOTH medical devices and pharmaceuticals is highly preferred

WORK DETAILS

• - Location: Makati City


• - Schedule: Monday to Friday, 8:00 AM to 5:00 PM


• - Requirement: Willingness to conduct field work for government agency transactions