Regulatory Compliance Specialist

2 days ago


Beijing, Beijing, China Parexel Full time
Job Description

We are seeking a highly motivated and experienced Regulatory Compliance Specialist to join our team at Parexel. As a key member of our operations team, you will be responsible for ensuring the timely and accurate completion of project goals and updating applicable trial management systems.

Key Responsibilities:
  • Act as Parexel's direct contact with assigned sites, accountable for quality and delivery during the start-up phase.
  • Build relationships with investigators and site staff.
  • Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements.
  • Evaluate overall compliance and performance of sites and site staff: provide recommendations regarding site-specific actions and use judgment and experience to assess the ability and motivation of site staff.
Requirements:
  • Bachelor's degree in biological science, pharmacy, or other health-related discipline preferred.
  • Previous relevant work experience preferred.
  • Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.
  • Sound interpersonal, verbal, and written communication skills.
Estimated Salary:

$60,000 - $80,000 per year.

About Us

Parexel is a leading global biopharmaceutical services company that provides end-to-end solutions for clinical trials and commercialization.



  • Beijing, Beijing, China Pfizer Full time

    Job SummaryThe Regulatory Compliance Specialist assists with the maintenance of a portfolio of products in China, ensuring compliance with local and international regulatory requirements. This role involves preparing regulatory submissions, collaborating with internal teams, and maintaining knowledge of relevant legislation.Key ResponsibilitiesPrepare...


  • Beijing, Beijing, China Novo Nordisk AS Full time

    Key ResponsibilitiesDevelop and implement effective regulatory strategies to ensure compliance with industry regulations and standards.Lead and coordinate the submission and approval processes for new products, licenses, and variations.Establish and maintain a robust regulatory compliance system to ensure adherence to industry standards.Foster...


  • Beijing, Beijing, China Galderma Full time

    Galderma offers an exciting opportunity for a highly skilled Regulatory Affairs Manager to join our team.The successful candidate will be responsible for preparing and submitting regulatory applications to obtain approval, including new products and existing license renewals and variations. This role requires strong analytical skills to monitor regulation...


  • Beijing, Beijing, China Brenntag Full time

    Our team in Beijing is seeking a Regulatory Compliance Manager to lead our Global Sourcing efforts. In this role, you will collaborate with our GSO Regulatory Manager and senior management to ensure compliance with Brenntag requirements and international standards.Key Responsibilities:Develop and implement compliance processes to ensure GSO suppliers meet...


  • 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...


  • Beijing, Beijing, China PATH Full time

    PATH is seeking a highly experienced Regulatory Compliance Specialist to support the vaccine manufacturing industry in China and Southeast Asia. Key responsibilities include strengthening cGMP activities and capabilities of vaccine and drug manufacturers, providing technical and manufacturing quality support, and building strong collaborative relationships...


  • 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 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...


  • 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...


  • 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...


  • 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...


  • 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 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 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...


  • Beijing, Beijing, China Novo Nordisk Full time

    Job Summary:We are seeking a highly skilled Regional Compliance Specialist to join our team at Novo Nordisk. As a key member of our compliance function, you will be responsible for ensuring that our regional operations are in compliance with all relevant laws and regulations.Key Responsibilities:Develop and implement effective compliance programs and...


  • Beijing, Beijing, China Galderma Full time

    DescriptionTo oversee the regulatory aspects of product registration, ensuring compliance with NMPA requirements. Collaborate with cross-functional teams to prepare and submit applications, and maintain relationships with regulatory authorities.Key ResponsibilitiesDevelop and implement regulatory strategies to support product launches and renewals.Lead...


  • Beijing, Beijing, China Parexel Full time

    About the JobWe are seeking a highly skilled Clinical Research Associate I to join our team at Parexel. As a key member of our organization, you will be responsible for ensuring the overall integrity of study implementation and adherence to study protocol at clinical sites.Job DescriptionThe successful candidate will have experience in conducting site...

  • Regulatory Specialist

    3 weeks ago


    Beijing, Beijing, China TÜV Rheinland Full time

    Job DescriptionAs a Regulatory Specialist at TÜV Rheinland, you will be responsible for classifying and judging medical devices according to the MDR regulation. Your tasks will include checking the completeness of technical documents, preparing audit documents, and following up on audit projects.RequirementsTo succeed in this role, you will need a Master's...


  • Beijing, Beijing, China Brenntag Full time

    Brenntag is a leading global full-line distributor of chemical bulk products and services with operations in over 70 countries.SalaryThe estimated annual salary for this role is $120,000 - $180,000 based on industry standards and location.Job DescriptionThis Deputy Regulatory Manager - Global Sourcing position plays a crucial role in ensuring compliance and...


  • Beijing, Beijing, China Lenovo Full time

    About the RoleWe are seeking a highly skilled Data Security Compliance Specialist to join our team at Lenovo.Key Responsibilities1. Collaborate with our cross-functional teams to develop and implement data protection strategies, ensuring compliance with relevant laws and regulations.2. Provide expert support for business operations, reviewing data compliance...