Responsible for Imported BDI_PI Products Regulatory Affairs KEY RESPONSIBILITIES(主要职责) - Maintain current NMPA approved certificates, including extension registration, change registration and support BU&RC to resolve post-marketing issues. - Make charge of new products launch in China, including make strategy, control registration timeline, type test, prepare registration documents, following evaluation and get approval. - Host regular meeting with WW to get requested documents and update registration status. - Follow NMPA regulations and analysis impacts to BD or responsible products. Other affairs within the team.
SKILLS AND ABILITIES(技能) - Medical/Pharmacy background, relevant experience on regulatory affairs - Bachelor degree or above - At least 2 years of regulatory affairs experience - Proficient in spoken and written English and Chinese - Ability to work independently and experience in a team on multiple projects Excellent interpersonal and communication skills
DESIRABLE(优先条件) - Medical device company working experience - Overseas education background