Deskripsi Pekerjaan
Join Terumo, a global healthcare leader, as a Regulatory Affairs Staff/Officer and drive compliance excellence in pharmaceutical and medical device regulations. This pivotal role involves managing end-to-end product registration and renewal processes, ensuring seamless market access for life-saving medical innovations. You'll prepare and submit comprehensive regulatory documentation to health authorities, respond to customer inquiries for regulatory compliance materials, and maintain meticulous documentation systems. Stay ahead of evolving regulatory landscapes across local and international markets, providing critical guidance to cross-functional teams including R&D, Quality Assurance, and Marketing. Your expertise directly impacts patient access to innovative therapies while maintaining Terumo's commitment to safety and efficacy standards. This position offers dynamic growth opportunities in a collaborative environment dedicated to advancing global healthcare outcomes.
Tanggung Jawab
- Manage full product lifecycle registration and renewal processes for pharmaceutical and medical devices
- Prepare and submit regulatory documentation to Philippine FDA and international health authorities
- Handle customer requests for regulatory compliance documentation and certificates
- Monitor regulatory changes and update internal compliance frameworks accordingly
- Collaborate with R&D, QA, and Marketing teams to support regulatory submissions
- Maintain organized regulatory files and documentation for audit readiness
- Ensure adherence to GMP, ISO, and other industry-specific regulatory standards
Kualifikasi
- Bachelor's degree in Pharmacy, Chemistry, Biology, or related life sciences field
- 1-2 years of regulatory affairs experience in pharmaceutical or medical device industry
- Strong knowledge of Philippine FDA regulations and international regulatory frameworks
- Proficiency in regulatory documentation preparation and submission processes
- Exceptional attention to detail with strong organizational and documentation skills
- Excellent communication and interpersonal skills for stakeholder collaboration
- Ability to work independently and manage multiple deadlines in a fast-paced environment