Senior Regulatory Affairs CMC Manager

3 weeks ago


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

Key Responsibilities:

As a Senior Regulatory Affairs CMC Manager at 1215 GlaxoSmithKline (China) Investment Co Ltd, you will be responsible for providing strategic and technical regulatory input for the purpose of commencing and maximizing GSK China business by facilitating the CMC submission and approval in a timely and high-quality manner.

Key Accountabilities:

  • Develop and implement CMC regulatory strategies for new and established products.
  • Provide regulatory support for CMC document preparation, CDE CMC technical review follow-up, HA CMC meeting or communication for CMC topics, QC testing, GMP on-site inspection, ChP, bundling review, etc.
  • Collaborate with internal stakeholders to ensure timely and high-quality CMC filing and approval.
  • Establish and maintain relationships with key CMC regulatory authorities in China.
  • Ensure compliance with company SOPs and regulatory requirements.


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

    Job Summary:We are seeking a highly skilled Senior RA CMC 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 1215 GlaxoSmithKline (China) Investment Co Ltd Full time

    About the RoleWe are seeking a Senior Manager CMC Regulatory Affairs Professional to join our team at 1215 GlaxoSmithKline (China) Investment Co Ltd.Job SummaryThis role is responsible for providing strategic and technical regulatory input for new and established products, ensuring timely and high-quality CMC submissions and approvals in China.Key...


  • Beijing, Beijing, China Bristol Myers Squibb Full time

    Transform Your Career with Bristol Myers SquibbBristol Myers Squibb is a company that transcends the ordinary. We're not just another pharmaceutical company; we're a group of innovators, researchers, and problem solvers who are passionate about transforming patients' lives through science.A Day in the Life of a Regulatory Affairs Manager - China CMCAs a...


  • Beijing, Beijing, China Bristol Myers Squibb Full time

    Transforming Patients' Lives through ScienceBristol Myers Squibb is a global biopharmaceutical company that is transforming patients' lives through science. We are seeking a highly skilled and experienced Regulatory CMC Lead to join our team in China.Key Responsibilities:Ensure regulatory compliance with government policy and company required SOPs.Support...


  • Beijing, Beijing, China Pfizer Full time

    Job SummaryPfizer is seeking a highly skilled Regulatory Affairs Manager to join our team in China. The successful candidate will be responsible for leading the development and implementation of regulatory strategies for our CMC products, ensuring compliance with China regulations and guidelines.Key ResponsibilitiesDevelop and implement regulatory strategies...


  • Beijing, Beijing, China Pfizer Full time

    About the RoleThis is an exciting opportunity for a seasoned Regulatory Affairs professional to join Pfizer's Global Regulatory Solutions (GRS) team in China. As a key member of our GRS CMC China team, you will play a crucial role in ensuring compliance with regulatory requirements and guidelines across various jurisdictions.Key ResponsibilitiesServe as a...

  • CMC Regulatory Expert

    2 weeks ago


    Beijing, Beijing, China Novo Nordisk Full time

    At Novo Nordisk, we are seeking a CMC Regulatory Expert to join our team. This role will be responsible for regulatory planning and strategy development, including submissions and approvals for CMC issues relevant to new products, license renewals, variations, annual reports, and deregistrations.Key ResponsibilitiesDevelop and implement regulatory plans and...

  • CMC Regulatory Lead

    2 weeks ago


    Beijing, Beijing, China Bayer Full time

    Your Key ResponsibilitiesAt Bayer, we strive to make a significant impact on the worldAssociate RA CMC Director Key Tasks and ResponsibilitiesRegulatory Strategy and PlanningDevelop and implement regulatory strategies for marketed chemical and bio-products, CTA, NDA in China.Timely tracking and updating project QC testing and CMC review status.Foreseeing...


  • Beijing, Beijing, China Pfizer Full time

    Job DescriptionPfizer is seeking a highly skilled Regulatory CMC Director to join our team in China. As a key member of our GRS CMC China team, you will be responsible for leading the development and execution of global regulatory strategies for projects across all aspects of drug development or manufacturing lifecycle.Main ResponsibilitiesCollaborate with...


  • Beijing, Beijing, China Bayer Full time

    OverviewBayer, a global leader in healthcare and agriculture, is seeking an experienced Regulatory Affairs Director to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring the successful registration and compliance of our chemical and biopharmaceutical products in China.


  • Beijing, Beijing, China Bristol Myers Squibb Full time

    Transforming Patients' Lives through ScienceAt Bristol Myers Squibb, we are dedicated to developing innovative treatments that improve the lives of patients around the world. We are seeking a highly skilled CMC Regulatory Affairs Expert to lead our China operations and ensure compliance with regulatory requirements.Key Responsibilities:Develop and...


  • Beijing, Beijing, China Bayer Full time

    At Bayer, we're driven to solve the world's toughest challenges and strive for a world where health for all and hunger for none is a real possibility.Associate RA CMC DirectorYour Key ResponsibilitiesDevelop and implement strategies for marketed chemical and bio-products in China, including dossier preparation, QC testing, and timely tracking of project...


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

    Job Summary:We are seeking a highly skilled Regulatory Affairs Manager to provide strategic and technical regulatory support to our line manager. The successful candidate will play a critical role in facilitating the submission and approval of our products in a timely and high-quality manner.Key Responsibilities:Provide strategic and technical regulatory...


  • Beijing, Beijing, China Novo Nordisk AS Full time

    About the RoleWe are seeking a highly motivated and experienced Regulatory Affairs professional to join our team at Novo Nordisk A/S. As a key member of our Clinical Medical Regulatory and Quality department, you will play a critical role in driving innovation and transforming the treatment paradigm for chronic diseases.Key ResponsibilitiesDevelop and...


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

    Job Purpose:The Head of Regulatory Affairs, China will provide strategic direction for the GSK China Regulatory Affairs team. The role will ensure the registration of new products and line extensions and manage the life cycle of the products in line with commercial and global regulatory objectives. The role will maintain strategic relationships with key...


  • Beijing, Beijing, China Hologic, Inc. Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Hologic, Inc. This role will be responsible for establishing and maintaining registration plans for medical devices, forecasting and managing project budgets, and coordinating submissions to regulatory agencies.Key ResponsibilitiesDevelop and execute registration...


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

    Job DescriptionHead of Regulatory Affairs for GSK in China will provide leadership and strategic direction for the company's regulatory affairs team. The role involves ensuring the registration of new products and line extensions, managing the life cycle of products, and aligning with commercial and global regulatory objectives.About the RoleLead a team of...


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

    Role Overview:We are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team at GSK China. As a key member of our regulatory affairs team, you will be responsible for providing strategic and technical regulatory support to our line manager to ensure timely and high-quality submission and approval of our products in the...


  • Beijing, Beijing, China Takeda Full time

    Job Summary:We are seeking a highly skilled Regulatory Affairs Manager to join our team at Takeda. In this role, you will be responsible for product registration and application for approval in accordance with the company's product launch strategy and department's work plan.Key Responsibilities:Develop and implement product registration plans by stage,...


  • Beijing, Beijing, China Hologic, Inc. Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Hologic, Inc. The successful candidate will be responsible for ensuring compliance with regulatory requirements and guidelines for medical device registration.Key ResponsibilitiesEstablish and maintain registration plans for medical devices, ensuring compliance with...