Licensed Pharmacist for Regulatory Affairs

BCP Dermatological Corporation; Pasig; On-site; PHP 334,800 - 558,000; Full time

Job summary

A healthcare company based in Metro Manila is seeking a regulatory specialist to ensure compliance with FDA regulations and prepare product registration documents. Responsibilities also include renewing memberships with PhilGEPS, reviewing packaging layouts, and coordinating with various government agencies. The ideal candidate should be detail-oriented and possess strong communication skills to negotiate with regulatory authorities. This position offers opportunities for interaction with multiple government entities.

Responsibilities

• Ensure that the company's products comply with FDA regulations.
• Prepare documents for timely submission of Licenses of Product Registration applications.
• Responsible for the renewal of PhilGEPS membership.
• Review packaging layouts and promotional materials according to FDA standards.
• Negotiate with regulatory authorities for marketing organization.

Job description

• Ensure that the company's products comply with FDA regulations
• Prepare documents for timely submission of Licenses of Product Registration (Initial, Renewal and Variation) applications
• Prepare documents for Cosmetic Notification application
• Responsible for the renewal of PhilGEPS membership
• Write clear, accessible product labels and patient information leaflets
• Review packaging lay outs and promotional materials in line with the existing standards set by FDA
• Specific storage, labeling and packaging requirements
• Coordinate with FDA , DOH, IPO, PhilGEPS and other government agencies on a regular basis or as deemed necessary
• Negotiate with regulatory authorities for marketing organization
• Keep abreast of international legislation , guidelines and customer practices
• Other tasks will be discussed during interview