Deskripsi Pekerjaan
Join XU RI Trading Corp. as a Regulatory Pharmacist and become a pivotal force in ensuring compliance and excellence in the healthcare and cosmetics industry. This critical role demands expertise in navigating the complex regulatory landscape to bring innovative products to market safely and efficiently. You will spearhead all regulatory documentation processes, including License to Operate (LTO) applications and renewals, as well as cosmetic product notifications, ensuring full adherence to Philippine FDA and DOH standards. Your meticulous approach will safeguard our product integrity while enabling timely market access. Collaborate with cross-functional teams to translate regulatory requirements into actionable strategies, maintaining meticulous documentation and staying ahead of evolving compliance mandates. This position offers the opportunity to make a tangible impact on public health while advancing your career in a dynamic, growth-oriented environment.
Tanggung Jawab
- Manage end-to-end application and renewal processes for pharmaceutical and cosmetic product Licenses to Operate (LTO)
- Prepare and submit comprehensive product notifications for cosmetics to regulatory authorities
- Ensure strict compliance with FDA, DOH, and international regulatory standards
- Maintain and update regulatory documentation, dossiers, and compliance records
- Monitor regulatory changes and advise internal stakeholders on compliance requirements
- Collaborate with R&D, quality assurance, and production teams on regulatory strategy
- Represent the company in communications with regulatory bodies and industry partners
Kualifikasi
- Valid Philippine Pharmacist license (PRC registration)
- Bachelor's degree in Pharmacy or Pharmaceutical Sciences
- Minimum 2 years' experience in regulatory affairs, preferably in pharmaceuticals/cosmetics
- Deep understanding of Philippine FDA and DOH regulations
- Proficiency in regulatory documentation and submission processes
- Strong analytical skills and attention to detail
- Excellent written and verbal communication skills