Regulatory Affairs Pharmacist

Fixus Enterprises; Quezon City; On-site; PHP 446,400 - 669,600; Full time

Job summary

A healthcare company in Quezon City is seeking a Regulatory Affairs Officer responsible for ensuring compliance with FDA regulations concerning medical devices. Key tasks include managing registration dossiers, conducting compliance audits, and collaborating with cross-functional teams. Ideal candidates hold a Bachelor's degree in Pharmacy and possess strong communication and analytical skills. Experience in regulatory affairs is preferred but not required, and training will be provided.

Qualifications

• Experience with regulatory compliance is desirable, but fresh graduates may apply.
• Willingness to undergo further training is needed.

Responsibilities

• Ensure medical devices meet regulatory requirements and standards.
• Prepare and manage product registration dossiers and renewals.
• Review marketing materials for compliance with regulations.
• Maintain accurate regulatory documentation and report to FDA.
• Collaborate with teams for regulatory submissions.
• Stay updated with regulatory changes and implement updates.

Skills

Excellent written and verbal communication skills

Strong understanding of Philippine FDA regulations

Ability to work under pressure with minimum supervision

Excellent analytical skills

Education

Bachelor of Science in Pharmacy degree

Job description

On-site - Quezon City; 3-5 yrs exp; Master; Full-time

Job Description

Responsibilities

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

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.

Working Location

On-site in Quezon City. This position requires physical presence at the workplace as stated.