Regulatory Affairs Executive

1 week ago


Makati City, National Capital Region, Philippines Allegens Healthcare Full time

Makati, National Capital Region, Philippines

Regulatory Affairs Executive

Allegens Healthcare Makati, National Capital Region, Philippines

  • Prepare, check, compile and submit the company's product registration dossiers including drugs, functional foods, medical devices, cosmetics, etc. (including new registration dossiers/ renewal dossiers/ supplementary dossiers/ change 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 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 regulatory submissions and approvals.
  • Collect and store complete and accurate documents, dossiers and dossiers.
  • Coordinate with internal departments to ensure compliance with regulatory requirements.
  • Update knowledge and requirements according to FDA regulations
  • Support product labeling, packaging, and promotional materials compliance.
  • Build good relationships and company image with FDA.
Qualifications
  • Graduated from university or college
  • Experience 2-3 years as regulatory affairs for drug registration
  • Fluent in English
  • Professional attitude and appearance
  • Solid written and verbal communication skills
  • Ability to be resourceful and proactive when issues arise
  • Excellent organizational skills
  • Multitasking and time-management skills, with the ability to prioritize tasks

Salary Range: Negotiable

Working Time: 08:00 – 17:00 (Mon – Fri, alternate Saturday), lunch time: 12:00 – 13:00

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Business Development and Sales

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