Be responsible for the preparation, compilation, and submission of all regulatory dossiers for both medical devices and pharmaceuticals, including product registrations, site registrations, license maintenance, and product variations.
Timely tracking and reporting of submission status and progress to stakeholders. 2. Strategic Regulatory Planning:
Support in creation of regulatory strategy for the company's product portfolio including product renewals, ensuring streamlined cross-functional collaboration for business continuity and accelerate market entry.
Internal and External Coordination:
Efficiently communicate and collaborate with the Product Center RA team for all regulatory needs and ensure accurate and complete dossier collection.
Act as the primary liaison for communication with the TFDA and actively maintain networking with the local industry community.
Requirements
Work experience: Minimum of 5 years of hands-on experience in the above Regulatory Affairs related work in Taiwan.
Educational Requirements: Bachelor's or Master's Degree
Academic Requirement: Science-related, Pharmacy, Medical-related, or a related discipline.
Language Proficiency: Chinese: Native speaker, and English Listening / Fluent, Speaking / Fluent, Reading / Fluent, Writing / Fluent
Proficient in : ExcelOutlookPowerPointWord
Core Competencies: Solid knowledge and understanding of relevant Medical Devices or Pharmaceutical regulations (e.g., TFDA, US FDA, EU MDR, etc.).
Others:
Excellent interpersonal, writing, and verbal communication skills are required.
Highly capable of prioritizing projects and efficiently managing multi tasks.
Proven ability to deliver results on time in a fast-paced environment.
Ability to interact with internal and external business partners in a professional and collaborative manner.
