Regulatory Compliance Specialist

2 days ago


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 with industry partners.

Responsibilities:

  • Strengthen cGMP activities and capabilities of vaccine and drug manufacturers in China (70%) and in Southeast Asian countries (30%) ensuring that regulatory inspections (NRA, WHO) yield successful and sustainable outcomes.
  • Provide continued technical and manufacturing Quality support for ensuring robust and sustained manufacturing of quality vaccines and drugs that meets local and global demands.
  • Become a resource and a trusted partner by way of building strong collaborative professional relationship with vaccine and drug manufactures in China and in Southeast Asia.
  • Provide technical / manufacturing guidance to vaccine and drug manufacturers and help them improve and maintain technical capabilities for robust and sustainable operation that supplies forecasted demands.
  • Review plans against Quality Assurance and Quality Control requirements including WHO Prequalification standards. Analyze risks, opportunities, and challenges, seek solutions, and supervise project implementation to ensure achievement of targeted milestones.
  • Provide strategic and technical guidance to the PATH China office and Global CVIA Quality and CMC functions.
  • Conduct Mock Inspection, technical (process development/manufacturing/quality assurance) due diligence of vaccine and drug manufactures as required.
  • Review remediation and CAPA plans, as necessary.
  • Provide GMP and Quality System training, as necessary.
  • Determine GMP Certificate suitability.
  • Provide technical review of pharmaceutical plans and technical documentation relative to vaccine and drug manufacturing facilities.
  • Engage as needed SMEs/ Consultant support in delivering set goals.
  • Time allocation: 70% for China and 30% for the rest of Asia- 70% for vaccines and 30% for drugs.

Required Experience:

  • A Relevant bachelor's degree plus a minimum of 15 years of experience in vaccine/biologics/drug manufacturing under compliant environment (cGMP) that is suitable for regulatory submission and licensure.
  • Planning, conducting, collaborating, managing, or overseeing cGMP manufacturing, and Quality, and conducting due diligence activities.
  • Experience with pharmaceutical quality operations is critical for the job as is auditing experience. Certification from a Quality Organization (CQA from ASQ, for example) is a big plus.
  • Knowledge of vaccine, drug and biologics development and manufacturing (cGMP) in developed and developing countries is a plus.
  • Experience in applying US and international (including WHO) quality requirements in the context of regional and international regulatory expectations.
  • Proven ability to conduct internal or external quality assurance auditing of manufacturing facilities and operations and in developing remediation plan for execution.
  • Experience managing complex international projects involving vaccines, drugs, or biologics.
  • Experience in technical report review.
  • Written and oral communication skills in Chinese and English are required.
  • Ability to travel internationally and within China up to 50 percent.

Location: China



  • 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 Abbott Full time

    Key Responsibilities:As a Regulatory Affairs Specialist at Abbott, you will be responsible for the registration of medical devices, IVDs, and/or drug products. This includes ensuring timely submission of applications for new product registration, variations of marketed products, and license renewals, in compliance with NMPA/CMDE requirements and internal...


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

    Job SummaryWe are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our team at Hologic, Inc. in [Location].Key ResponsibilitiesDevelop and maintain registration plans for medical devices, ensuring compliance with regulatory requirements.Coordinate with cross-functional teams to ensure timely and accurate submissions to...


  • 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 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 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 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 Abbott Full time

    Job Summary:Abbott is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements for medical devices, IVDs, and drug products.Key Responsibilities:Registration of medical devices, IVDs, and/or drug productsApplications for New...


  • 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 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 horizons, enhance our skills, and redefine what is possible. There are...


  • 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 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 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 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 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 Novo Nordisk AS Full time

    Key ResponsibilitiesWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Novo Nordisk A/S. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines.Develop and implement regulatory strategies to support the launch and maintenance of our pharmaceutical...


  • Beijing, Beijing, China Novo Nordisk Full time

    Key ResponsibilitiesAs a Regulatory Affairs Manager at Novo Nordisk, you will play a critical role in ensuring the company's products meet regulatory requirements and are approved for market access. Your key responsibilities will include:Developing and implementing regulatory strategies to support product launches and lifecycle management.Preparing 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...