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Regulatory Affairs Coordinator

1 week ago

Manila, National Capital Region, Philippines Manpower (Philippines) Full time

At Manpower (Philippines), we are seeking a Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring the timely preparation and submission of product dossiers to Health Authorities in the Philippines.

Responsibilities
  1. We are looking for a detail-oriented individual who can prepare and compile assigned product dossiers for HA submission, including the preparation of Module 1 local documents such as the Application form, cover letter, and commitment letter.
  2. The successful candidate will collaborate with various stakeholders to ensure the timely receipt of supporting documents and submissions.
  3. You will be responsible for conducting change control assessments and providing filing strategies for Philippines HA.
  4. This role requires strong communication skills, as you will provide necessary guidance to various stakeholders for Philippines HA.
  5. The ideal candidate will submit dossiers/supportive documents to Health authorities on time and proactively communicate with all stakeholders on approval and implementation.
  6. Additionally, you will track and follow-up on submissions with HAs for status and approval, as well as respond to queries from Health authorities in a timely manner.
  7. You will also be responsible for updating and maintaining submission trackers, as well as updating regulatory guidance databases based on the latest local regulatory information of the Philippines and updated guidelines.
  8. This role involves artwork-related activities, such as initiating artwork requests/mock-ups, tracking artwork requests, reviewing and approving country-specific artworks.
  9. Supporting agency requests with post-marketing samples/declarations/certificates is also an essential part of this role.

Seniority Level: Associate

Employment Type: Contract

Job Function: Health Care Provider

Industries: Health and Human Services