Regulatory Affairs Manager

2 weeks ago


Beijing, Beijing, China Novo Nordisk AS Full time

About the Role

We 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 Responsibilities

  • Develop and implement regulatory strategies to ensure compliance with international regulations and guidelines.
  • Prepare and submit regulatory documentation, including submissions and approvals for new products, license renewal, variation, and registration.
  • Collaborate with cross-functional teams to ensure regulatory influence and compliance.
  • Provide guidance and support to team members on regulatory affairs and compliance matters.
  • Stay up-to-date with changes in regulatory requirements and guidelines, and ensure that our processes and procedures are aligned.

Requirements

  • Relevant graduate-level degree, e.g., Pharmacy, Pharmacology, Biology.
  • Fluency in both written and spoken English.
  • Minimum 3 years of experience in the pharmaceutical industry or related industries, such as medical devices or healthcare.
  • Experience in regulatory affairs or medical departments, with a preference for international pharmaceutical companies.
  • Strong analytical and problem-solving skills, with the ability to work independently and as part of a team.
  • Excellent communication and interpersonal skills, with the ability to build strong relationships with stakeholders.

About Us

Novo Nordisk A/S is a global healthcare company dedicated to driving innovation and improving the lives of patients worldwide. Our Clinical Medical Regulatory and Quality department is committed to bringing our products to market with the fastest speed and top quality, while applying the most scientific approach to communicate our products' benefits to customers.



  • 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 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 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 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 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...


  • 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 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 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...


  • 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 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 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 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 Takeda Full time

    About the RoleWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Takeda in Beijing. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with drug administration and registration management regulations.Key ResponsibilitiesDevelop and implement product registration plans, coordinating with...


  • 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...


  • 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...


  • 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 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...


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

    Job DescriptionWe are seeking a highly skilled Global Regulatory Affairs Leader to join our team at 1215 GlaxoSmithKline (China) Investment Co Ltd. As a key member of our organization, you will be responsible for providing strategic and technical regulatory support to our line manager.Key Responsibilities:Provide high-quality regulatory input and advice on...