Toxicologist Program Manager

Major Responsibilities：

• Assist with design, execution and interpretation of preclinical, toxicologic evaluation programs specific to CFDA requirements; including direct testing, review of literature, and assessment of compliance. Collaborate with the company project teams, local Regulatory, Medical Affairs, R&D and outside resources as required.
• Act as direct liaison with CFDA on matters related to medical device product evaluation and registration requirements; including specific materials of concern, local standards, state laboratory methods and operations, and other relevant topics.
• Provide input and expertise for assessment of programs and processes, including assessment of current best practices in the context of CFDA. Participate in China industry or advocacy groups to contribute to standards development and regulatory policy, and advance company product positioning.
• Manage projects as assigned, including coordination of laboratory and sponsor activities. This may include selection and oversight of local (China) preclinical testing as appropriate.
• Assist with operational activities, including reviews of Assessment of Change Requirements (ACR) submissions specific to the China market. Assist and support development of documentation, summaries and interpretation of preclinical evaluations as required for regulatory registration and compliance, and support of product marketing in China.
• Maintain knowledge of activities in the medical, product and regulatory arenas to assure compliance and conformance of the department programming; to include medical devices as well as drugs and/or biologics as necessary for successful marketing in China.

Required：

• University degree in toxicology or a closely related field required, advanced degree (Ph.D.) preferred, board certification in toxicology preferred (Diplomate of the American Board of Toxicology). A broad background in biology/toxicology and chemistry including familiarity with recent methodologies and evaluation techniques. Experience in CFDA regulatory industry environment essential. Ability to communicate and work effectively across a wide national and international internal and external client base. Must be able to multitask and operate effectively within a diverse work environment. Must be team oriented and have strong interpersonal skills and customer focus. Must have excellent scientific written and verbal communication skills. Native speaker preferred, fluency in English required.