Job Description
English Language
Pharmaceutical
Description :
- Regulatory Submissions: Prepare, review, and submit product registration applications for medical devices, diagnostic reagents, and medical equipment to the Philippine FDA.
- Compliance Monitoring: Ensure that all products comply with the regulatory requirements of the Philippine FDA, including standards for safety, efficacy, and labeling of medical devices and machines.
- Product Documentation: Maintain and update technical documentation, product dossiers, and ensure timely submission of regulatory documents and reports.
- Liaison with FDA and Authorities: Serve as the primary point of contact with the Philippine FDA and other regulatory bodies to facilitate product approvals, renewals, and post-market surveillance activities.
- Regulatory Strategy: Develop and implement regulatory strategies to optimize registration timelines and ensure smooth market access for new and existing products.
- Cross-functional Collaboration: Work closely with the R&D, Quality Assurance, and Marketing teams to ensure all products meet regulatory requirements throughout their lifecycle.
- Training and Updates: Stay informed on changes in local and international regulations and provide regulatory training and updates to internal teams.
- Department: Regulatory Affairs
- Reports To: Regulatory Manager
Requirements :
- Licensed Pharmacist in the Philippines.
- Minimum of 5 to 10 years of experience in regulatory affairs, specifically with medical devices, reagents, or machines or in similar industry.
- In-depth knowledge of Philippine FDA regulations related to medical devices, diagnostic reagents, and medical equipment.
- Strong understanding of product registration processes and post-market compliance.
- Excellent communication and interpersonal skills to liaise with regulatory bodies and internal teams.
- Detail-oriented, with strong organizational and project management abilities.
- Ages from 28 to 35
Active today
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Working Location
4/F, Wilson Corporate Center, WSC Corporate Center, 225 Wilson, San Juan, 1502 Metro Manila, Philippines