Regulatory Affairs Officer - Manila - ref. b04661303

ALLEGENS HEALTHCARE PHILIPPINES INC is hiring a Full time Regulatory Affairs Officer role in Legazpi Village, NCR. Apply now to be part of our team.

Job summary:

• Looking for candidates available to work:
• Monday: Morning, Afternoon
• Tuesday: Morning, Afternoon
• Wednesday: Morning, Afternoon
• Thursday: Morning, Afternoon
• Friday: Morning, Afternoon
• 2-3 years of relevant work experience required for this role
• Expected salary: ₱30,000 - ₱45,000 per month

Allegens Healthcare Philippines Inc is an international corporate for importing and distributing diverse pharmaceutical and food products. We have head office in Vietnam and representative offices in Cambodia, Myanmar, India, Philippines, Hong Kong, Singapore,...

• Prepare, check, compile and submit GMP clearance and the company's products registration dossiers including drugs, functional foods/ foods supplement, medical devices, cosmetics, etc. (including Initial dossiers/ renewal dossiers/ supplementary dossiers/ variation dossiers).
• Responsible for ensuring that the dossiers are correct and accurate according to the regulations of the Pharmaceutical Law and current legal regulations of the FDA.
• Work with manufacturers and customers to provide documents and dossiers related to registration.
• Ensure the submission and approval of all delivered drugs within the optimal time schedule.
• Handle issues related to the Company's drug registration dossiers.
• Make periodic/ad hoc work reports as required by management.
• Manage documentation and track/follow up regulatory submissions and approvals.
• Coordinate with internal departments to ensure compliance with regulatory requirements.
• Update new regulations, circulars, requirements or laws to manager.
• In charge for product labeling, packaging, and promotional materials compliance
• Build good relationship, company image with FDA departments.
• Achieve target set up as per KPIs which decide by time to time.