Current jobs related to (Sr.) Regulatory Affairs Specialist - Beijing - Abbott

  • Regulatory Affairs Specialist

    2 days ago

    Beijing, Beijing, China Hologic, Inc. Full time

    Hologic, Inc. is seeking a highly skilled Regulatory Affairs Specialist to join our team.Job DescriptionThe ideal candidate will have more than 5 years of experience in regulatory affairs and related QA working experience in the medical device field.We are looking for someone who is familiar with imaging, surgical or IVD products and has a strong attention...

  • Regulatory Affairs Specialist

    4 weeks ago

    Beijing, Beijing, China Novo Nordisk Full time

    Are you passionate about driving innovation in the pharmaceutical industry? Do you want to make a difference in the lives of patients? We are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team at Novo Nordisk.About the RoleDevelop and implement regulatory strategies to ensure compliance with global...

  • Regulatory Affairs Specialist

    1 month ago

    Beijing, Beijing, China Novo Nordisk AS Full time

    Are you passionate about driving innovation in the pharmaceutical industry? Do you want to make a meaningful impact on the lives of patients? Novo Nordisk A/S is seeking a talented Regulatory Affairs Specialist to join our team.The PositionDevelop and implement regulatory strategies for new products and submissionsCollaborate with cross-functional teams to...

  • Regulatory Affairs Specialist

    2 weeks ago

    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...

  • Regulatory Affairs Specialist

    2 weeks ago

    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...

  • Regulatory Affairs Specialist

    4 weeks ago

    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...

  • Regulatory Affairs Specialist

    4 weeks ago

    Beijing, Beijing, China Novo Nordisk Full time

    Key ResponsibilitiesAs a Regulatory Affairs Specialist at Novo Nordisk, you will be responsible for planning and executing regulatory strategies to ensure compliance with global regulations. This includes submissions and approvals for new products, license renewals, variations, and deregistrations.QualificationsRelevant graduate-level degree in a field such...

  • Sr. Regulatory Affairs Supervisor

    3 months ago

    Beijing, China Novo Nordisk AS Full time

    Are you motivated by driving innovation for the life-changing benefit of patients? Are you ready to help transform the treatment paradigm for a broad range of chronic diseases that currently rely on injection-based therapies? Then this is your moment. Apply now and join Novo Nordisk. Together we can create life-changing innovation. Together we can make it...

  • Sr. Regulatory Affairs Supervisor

    3 months ago

    Beijing, China Novo Nordisk Full time

       Are you motivated by driving innovation for the life-changing benefit of patients? Are you ready to help transform the treatment paradigm for a broad range of chronic diseases that currently rely on injection-based therapies? Then this is your moment. Apply now and join  Novo Nordisk. Together we can create life-changing innovation. Together we can...

  • Regulatory Affairs Lead

    3 weeks ago

    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...

  • Regulatory Affairs Specialist

    2 weeks ago

    Beijing, Beijing, China Novo Nordisk Full time

    Key ResponsibilitiesDevelop and implement regulatory strategies for new products and license renewalsCollaborate with cross-functional teams to ensure regulatory compliance and system implementationSupport regulatory influence and contribute to the development of regulatory policiesQualificationsDegree in a relevant field, such as pharmacy, pharmacology, or...

  • Regulatory Affairs Specialist

    1 month ago

    Beijing, Beijing, China Novo Nordisk AS Full time

    Key ResponsibilitiesAs a Regulatory Affairs Manager at Novo Nordisk A/S, you will be responsible for ensuring compliance with regulatory requirements for new products, license renewals, and variations. This includes planning and executing regulatory submissions, managing regulatory systems, and collaborating with cross-functional teams.QualificationsTo be...

  • Regulatory Affairs Specialist

    3 weeks ago

    Beijing, Beijing, China AbbVie Full time

    Job SummaryThis role requires a highly skilled and experienced professional to oversee the medical device regulatory compliance process in China. The successful candidate will be responsible for ensuring that all products meet the required regulatory standards and will work closely with the global team to achieve this goal.Key ResponsibilitiesDevelop and...

  • Regulatory Affairs Manager

    2 weeks ago

    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...

  • Strategic Regulatory Affairs Director

    3 days ago

    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...

  • Regulatory Affairs Specialist

    1 month ago

    Beijing, Beijing, China Galderma Full time

    About the RoleWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Galderma. As a key member of our regulatory team, you will be responsible for preparing and submitting regulatory applications to obtain approval for new products and existing license renewals and variations.Key ResponsibilitiesWork closely with cross-functional...

  • Regulatory Affairs Manager

    4 weeks ago

    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...

  • Head of Regulatory Affairs Director

    1 month ago

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

    Job Purpose:As the Head of Regulatory Affairs, you will provide strategic direction and leadership to the GSK China Regulatory Affairs team. Your primary focus will be on ensuring the registration of new products and line extensions, as well as managing the life cycle of products in line with commercial and global regulatory objectives.Key...

  • Head of Regulatory Affairs, China

    4 months ago

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

    Job Purpose: Head of Regulatory Affairs will provide leadership and 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 stakeholder...

  • Regulatory Affairs Professional for Innovative Therapies

    3 days ago

    Beijing, Beijing, China Novo Nordisk AS Full time

    Are you passionate about driving innovation in the pharmaceutical industry and transforming the treatment paradigm for chronic diseases? Novo Nordisk A/S, a leading international pharmaceutical company, is seeking an experienced Regulatory Affairs Supervisor to join its team.The ideal candidate will have a strong background in regulatory planning,...

(Sr.) Regulatory Affairs Specialist

1 month ago

Beijing, China Abbott 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

REQUIREMENTS:

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. 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.