Regulatory Affairs Pharmacist

Fixus Enterprises

HK$4.2-4.8K[月薪]
现场办公 - 奎松市3 - 5 年經驗碩士全職
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職位描述

福利待遇

  • 法定福利

    13薪

簡介

  • As a Regulatory Affairs Officer, you will be responsible for ensuring that our medical devices meet all necessary regulatory requirements and standards.
  • Your key responsibilities will include product registration, compliance management, documentation and reporting, pharmacovigilance, communication and collaboration, and staying updated with regulatory changes. You will work closely with cross-functional teams to facilitate regulatory submissions and maintain compliance with FDA regulations.

Product Registration:

  • Prepare and submit comprehensive registration dossiers for medical devices.
  • Manage the renewal process for existing product registrations.
  • Monitor the status of registration applications and address any queries from the FDA.

B. Compliance Management:

  • Ensure adherence to all applicable regulatory guidelines regarding medical device labeling, packaging, and advertising.
  • Review and approve marketing materials to ensure accuracy and compliance with regulatory requirements.
  • Conduct regular internal audits to identify potential compliance issues and implement corrective actions.

C. Documentation and Reporting:

  • Maintain accurate and up-to-date regulatory documentation for all products, including product specifications, stability studies, and batch records.
  • Prepare and submit periodic reports to the FDA as required, such as adverse event reports and safety updates.

D. Pharmacovigilance:

  • Monitor and evaluate adverse reactions reported by healthcare professionals and consumers.
  • Report serious adverse events to the FDA according to established procedures.

E. Communication and Collaboration:

  • Collaborate with cross-functional teams including research and development, quality assurance, and marketing to facilitate regulatory submissions and compliance.
  • Liaise with the FDA on regulatory issues and provide necessary information for inspections.

F. Staying Updated:

  • Actively monitor changes in the regulatory landscape and implement necessary updates to company procedures.
  • Attend industry conferences and workshops to stay informed about new regulatory requirements.

職位要求

E. Qualifications:

  • Bachelor of Science in Pharmacy degree.
  • With or without a license.
  • With or without experience, but experience is a must.
  • Strong understanding of Philippine FDA regulations and guidelines.
  • Excellent written and verbal communication skills.
  • Ability to work under pressure with minimum supervision.
  • Willingness to undergo training.
  • Excellent analytical skills.
Attention to details
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Alyssa Niña Rose Claro

RecruiterFixus Enterprises

今天回覆 1 次

工作地址

306, 93 General Ave. 93 General Ave, Quezon City, 1116 Metro Manila, Philippines

發布於 07 April 2025

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