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Regulatory Affairs Pharmacist
4 weeks ago
Overview
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.
- 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.
- 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.
- 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.
- 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.
- 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.
