(Sr.) Manager, Regulatory Affairs-CMC

Description RA Manager , as an individual contributor, is responsible for developing regulatory strategy for the responsible projects with the guidance of senior regulatory manager; responsible for the regulatory strategy implementation by CTA/NDA submission/approval; responsible for HA interaction for regulatory strategy assessment with the guidance...

JOB SUMMARY Field based position responsible for developing and enabling MSL team to establish scientific leadership of AstraZeneca and build professional relationships with healthcare professionals. Acts as a leader and manager to MSL, providing training to MSL and implementing internal standards and processes. Works closely with the medical and...

Job OverviewThe Director of Quality and Regulatory Compliance, Eastern Asia will serve as a key member of the Global Sales Quality and Regulatory Affairs leadership team and the East Asia Region leadership team. This role will provide regulatory and quality leadership for the East Asia region, including China, Hong Kong, Taiwan, Macau, and Mongolia, where...

Requires in depth knowledge and experience of a specialist field and will be recognised expert. Works independently requiring only minimal guidance. Solves complex problems and takes a new perspective using existing solution. May act as a coach or team leader for technicians or lower level scientists. Major Responsibilities Leadership of group work and...

About the RoleWe are seeking a highly skilled Director of Quality and Regulatory Compliance for our East Asia region. This role will be responsible for providing regulatory and quality leadership for our operations in China, Hong Kong, Taiwan, Macau, and Mongolia.Key ResponsibilitiesWork closely with our East Asia QRC teams to ensure compliance with...

Job OverviewThe Director of Quality and Regulatory Compliance, Eastern Asia will serve as a key member of the Global Sales Quality and Regulatory Compliance leadership team and the East Asia Region leadership team. This role will provide regulatory and quality leadership for the East Asia region, including China, Hong Kong, Taiwan, Macau, and Mongolia, where...

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers. ...

Be responsible for the on time, quality, within budget delivery of global and local medical affairs clinical study and program for key products Prepare and deliver study level feasibility, and develop recruitment strategies , and the delivery of the approved Clinical Study Protocol .The job holder will lead a team to develop and deliver study results and...

J OB PURPOSE 工 作 目 的 Summarizes the job’s purpose or role and why it exists in the organization 概 述 工 作 的 目 的 或 角 色 及 其 在 机 构 内 的 价 值 Field-based position responsible for implementation of activities for establishment of scientific leadership of AstraZeneca. This includes development and enhancement of...

Responsible for products’ clinical development strategy and plan in multiple disease areas in R&D China. Responsible for managing reginal or China therapeutic or research projects or acting as an expert involved in the design, conduct, monitoring, data interpretation and reporting of individual clinical trials. Will provide some input to medical science...

RESPONSIBILITIES: Lead and coordinate a cross-functional study team of experts in accordance with STOM and its roles, accountabilities and responsibilities framework (RACI) to ensure the clinical study progress as planned driving achievement of milestones according to timelines, budget and quality standards Lead and facilitate communication across all...

Job SummaryWe are seeking a highly skilled and experienced Regional Operations Excellence and Quality Assurance Director to join our team at Huntsman. In this role, you will be responsible for driving continuous improvement initiatives across multiple departments and countries, with a focus on Lean Six Sigma principles and quality assurance.Key...

Job Description Component Strategy Development - Conduct market research on passive components, including packaging, specifications, and technological advancements. - Analyze the current and future product requirements of the automotive and networking industries. - Formulate recommendations for component selection based on market and industry...