Regulatory Affairs Specialist

2 months ago


Beijing, Beijing, China Abbott Laboratories Full time

Major Responsibilities

  • Responsible for registration of medical device, IVDs and/or drug products.
  • Responsible for the applications for New Product registration, variations of marketed products and license renewals within the set timeframe and conducting in compliance with NMPA/CMDE requirements as well as relevant internal SOP.
  • Responsible for providing relevant regulatory supports to other company personnel
  • Responsible for establishment of good working relationship with internal and external stakeholders to ensure effective product registrations.
  • Adhere to internal SOP and RA working procedures
  • Provide technical background and input to review cIFU and labeling translation.
  • Ensure that product is compliance with all applicable regulation and Chinese national panel/industry standard.
  • Sr. RA Specialist: Acknowledge the gap between NMPA regulation and EU/FDA regulation to establish the registration strategy.

Requirement

  • Bachelor or above
  • Regulatory Affairs Specialist: 2 yr + Registration or clinical related experiences
  • (Sr.) Regulatory Affairs Specialist: Minimum 4 years registration, clinical or regulatory policy and intelligence working experiences.
  • Good English communication skill

Work experience in multi-national company or government affiliates is a plus.



  • Beijing, Beijing, China Novo Nordisk Full time

    About the RoleWe are seeking a highly motivated and experienced Regulatory Affairs professional to join our team at Novo Nordisk. As a Regulatory Affairs Manager, you will play a key role in ensuring the compliance of our products with regulatory requirements and ensuring the smooth approval process of new products.Key ResponsibilitiesDevelop and implement...


  • Beijing, Beijing, China 1215 GlaxoSmithKline (China) Investment Co Ltd Full time

    Job Summary:We are seeking a highly skilled Senior Regulatory Affairs Manager to join our team at 1215 GlaxoSmithKline (China) Investment Co Ltd. As a key member of our regulatory affairs team, you will be responsible for providing strategic and technical CMC regulatory input to support the development and approval of new and existing products.Key...


  • Beijing, Beijing, China Bayer Full time

    About BayerBayer is a global leader in the life sciences, driven by a vision to make a difference in the world by improving people's lives. We're a community of innovators, thinkers, and doers who are passionate about solving the world's toughest challenges and striving for a world where 'Health for all, Hunger for none' is no longer a dream, but a real...


  • Beijing, Beijing, China Pfizer Full time

    Job SummaryWe are seeking a highly skilled and experienced Associate Director to join our Regulatory Affairs and Compliance team at Pfizer. The successful candidate will be responsible for leading the development and implementation of regulatory strategies for our CMC products, ensuring compliance with regulatory requirements and industry standards.Key...


  • Beijing, Beijing, China Bureau Veritas Group Full time

    Position Overview: The incumbent will play a pivotal role in assisting the management team in fostering communication with certification and testing authorities. This position involves overseeing documentation and information pertaining to regulatory and accreditation entities. The responsibilities will be executed within the framework of the BV Health,...


  • Beijing, Beijing, China Pfizer Full time

    Job SummaryThe Medical Affairs Effectiveness Specialist will be responsible for reviewing and managing external funding risk through effective models and procedures. This role will work closely with internal teams to improve efficient pre-approval processes and develop corporate risk strategies.Key ResponsibilitiesParticipate in medical governance...


  • Beijing, Beijing, China Bayer Full time

    At Bayer, we are innovators committed to addressing the world's most pressing challenges, working towards a future where 'Health for all, Hunger for none' becomes a reality. Our journey is fueled by energy, curiosity, and unwavering dedication, as we learn from diverse perspectives, broaden our horizons, enhance our skills, and redefine what is possible....


  • Beijing, Beijing, China Bayer Full time

    At Bayer, we are innovators committed to addressing the world's most pressing challenges, striving for a reality where 'Health for all, Hunger for none' is achievable. Our journey is fueled by energy, curiosity, and unwavering dedication, as we learn from diverse perspectives, broaden our understanding, enhance our skills, and redefine what is possible....


  • Beijing, Beijing, China Bristol Myers Squibb Full time

    Join Us in Transforming Lives At Bristol Myers Squibb, we believe in the power of science to change lives. Our work is not just about tasks; it’s about making a difference. Every day, our teams tackle unique challenges that contribute to groundbreaking advancements in healthcare. You will have the opportunity to grow in a diverse environment,...


  • Beijing, Beijing, China Bristol Myers Squibb Full time

    Transforming Patients' Lives through ScienceBristol Myers Squibb is a leading biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that transform patients' lives. We are seeking a highly skilled and experienced China Regulatory CMC Lead to join our team.About the RoleThe China Regulatory CMC Lead will be...


  • Beijing, Beijing, China Bristol Myers Squibb Full time

    Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...


  • Beijing, Beijing, China MSD Full time

    Job DescriptionChina Development Center seeks individuals to provide leadership and experience in conducting clinical research in China. One of the most important missions of clinical research in China is to shorten gap of the drug lag in China so effective treatment options become available to Chinese patients. This individual will be the key driver of...


  • Beijing, Beijing, China MSD Full time

    Job Description#Clinical ResearchChina Development Center seeks individuals to provide leadership and experience in conducting clinical research in China. One of the most important missions of clinical research in China is to shorten gap of the drug lag in China so effective treatment options become available to Chinese patients. This individual will be the...


  • Beijing, Beijing, China Duolingo Full time

    About DuolingoDuolingo is a leading education technology company that aims to make education fun, free, and accessible to everyone. We are passionate about developing innovative solutions to complex problems and making fact-based decisions.Job SummaryWe are seeking a highly skilled Director of Government Relations, China to lead our engagement with key...


  • Beijing, Beijing, China MSD Full time

    Job Description#Global Data Management StandardsUnder the direction of a manager, the Safety Data Specialist (SDS) (JPV) is responsible for analyzing, triaging and processing of all adverse experience information received for investigational and marketed products, according to standard operating procedures (SOPs) for further reporting to worldwide regulatory...


  • Beijing, Beijing, China DBS Bank Full time

    About the RoleDBS Bank is at the forefront of digital banking, and we're seeking a skilled professional to join our team as a Business Solution Delivery Specialist. In this role, you'll play a critical part in shaping our digital banking initiative, focusing on creating innovative products and services that integrate banking into our customers' digital...


  • Beijing, Beijing, China Ipsos Full time

    Position Overview: As a Biostatistics Specialist focused on Non-Interventional Studies (NIS) and Real-World Evidence (RWE), you will play a crucial role in ensuring the statistical integrity of our research projects.Key Responsibilities: Oversee the statistical components of study protocols, reports, and publications, guaranteeing the quality and accuracy of...


  • Beijing, Beijing, China Stryker (Beijing) Healthcare Products Co. Ltd Full time

    Job SummaryWe are seeking a highly skilled Clinical Sales Specialist to join our team at Stryker (Beijing) Healthcare Products Co. Ltd. As a Clinical Sales Specialist, you will be responsible for providing clinical sales support to end-users, providing on-site guidance and assistance during surgical procedures, and driving continuous account growth.Key...


  • Beijing, Beijing, China DBS Bank Full time

    Job SummaryDBS Bank is seeking a highly skilled Financial Operations Specialist to join our team. As a key member of our Operations department, you will be responsible for ensuring the smooth operation of our financial systems and processes.Key ResponsibilitiesVerify and reconcile daily settlements and confirmations.Process and review daily transactions in...


  • Beijing, Beijing, China DBS Bank Full time

    About the Role:The Data Enablement Specialist will play a crucial role in driving data usage across the ADA Lite platform at DBS Bank. As a key member of the data enablement team, this position will be responsible for engaging with business units and stakeholders to collect data requirements, propose executable solutions, and collaborate with technical teams...