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CMC Regulatory Affairs Director – China

Location Cambridge, England, United Kingdom Gaithersburg, Maryland, United States Södertälje, Stockholm County, Sweden Waltham, Massachusetts, United States Gothenburg, Västra Götaland County, Sweden Macclesfield, England, United Kingdom Job ID R-122323 Date posted 13/01/2022

Do you have experience in CMC Regulatory Strategy and China policy? Would you like to make a difference to the lives of millions of patients across the world? If you would, this could be the next role for you!

Join AstraZeneca, a place built on innovation and creativity. Where different views and perspectives are welcomed and valued. An environment that champions inclusion, and teams that reflect the diversity of the communities that we serve.

Our Chemistry, Manufacturing, and Controls (CMC) Regulatory functions span across the product lifecycle and are responsible for the regulatory strategy relating to the development, manufacture and testing of all of our medicines.

  • With our expertise we interpret, anticipate and shape global Health Authority expectations to create insightful CMC and Device Regulatory Strategies.
  • We are the bridge between our R&D functions, Operations sites, Quality and Global Supply Teams in helping safe, effective medicines reach the right patient at the right times. 
  • We manage the timely preparation and delivery of CMC contributions to the regulatory submissions linked to medicinal products’ throughout the commercial lifecycle; including marketing Authoring Applications (MAAs) and all post approval activities maximising the value of business critical Supply Chain changes to the AZ organisation by supplying the regulatory context, intelligence and guidance required to inform the development of robust plans for change initiatives.

Key Responsibilities, what you will be doing:

The role will be based in CMC Regulatory Affairs (CMC RA) reporting to the Group Manager for CMC Regional Strategy. You will develop expertise in current and emerging China regulatory guidance for CMC Biologics products across the lifecycle and will work with CMC RA colleagues to ensure that project strategies meet regulatory expectations. 

The position involves work closely with colleagues in China and Global China experts across Global Regulatory Affairs, Operations and Commercial. You’ll provide strategic, tactical, operational regulatory CMC expertise and direction to AstraZeneca products and project teams in support of Biologics portfolio throughout the life cycle and proactively share any new regulatory intelligence.

You will anticipate and proactively manage risks using evaluative judgements in complicated or novel situations. You will ensure the application of global CMC regulations and guidance within AstraZeneca and will contribute to development of new guidance, policy and processes. There is a requirement to set priorities and manage a high rate of legislative changes. 

You'll be proactive in advocacy and policy  activities associated with CMC Biologics legislative changes in China and be able to provide global insight to commenting requests, working closely with regulatory group based in China. 

You’ll ensure effective planning and information sharing activities with the key customers interface groups (within Operations, Global Regulatory Affairs and Commercial) and CMC Reg Affairs to support regulatory strategies, issue resolution and continuous supply over the lifecycle of the AZ Biologic product portfolio.

You will ensure performance standards that support maintenance of the CMC lifecycle and will develop senior level contacts with Global Regulatory Affairs, Global Operations, Regional Supply organisation and China Regulatory, in order to resolve issues that occur.

You'll support proactive management of AZ strategies in response to the changing regulatory landscape within China and the CMC regulatory intelligence trends and be responsible for the performance of the China CMC strategy team.

Required Skills & Knowledge:

  • Degree or equivalent professional qualification in a science or technical field such as pharmacy, biology, chemistry.
  • Experience of Biologics CMC and/or pharmaceutical and/or manufacturing and/or quality organisation in a biopharmaceutical field specifically working on biotechnology-based products or complex biologics
  • Breadth of knowledge of manufacturing, project, technical and regulatory management.
  • Fluent written and spoken Mandarin.
  • Excellent written and spoken English
  • Strong understanding of regulatory affairs in China & Globally.  Experience of regulatory health authority interactions, inspections and/or external advocacy/regulatory policy.

Desirable:

  • Post graduate qualification
  • Business, financial and supply chain understanding/awareness
  • Direct Regulatory Affairs CMC experience with submissions for biologic and biotechnology derived products such as monoclonal antibodies or complex biologic products is required
  • Technical experience in the testing or manufacture of biotechnology-derived products or complex biologics.

Our culture

Working on a strong pipeline means so much more than producing innovative, ground-breaking medicines. It allows us to be part of long-term development programs with the variety that comes from working at the leading edge of science and technology.

We explore innovations and confront challenges that others won't, to have a greater impact on patients' lives. We're proud of our pipeline – it’s not only changing the face of our industry for good and impacting the lives of patients, it’s transforming the careers of our people. We’re committed to a culture of continuous learning and people development so everyone at AstraZeneca can grow and thrive.

So, what’s next?

Are you already imagining yourself joining us? Good, because we can’t wait to hear from you!

Welcome with your application; CV and cover letter, no later than 4th February 2022

Salary: Competitive + Excellent Benefits

The role can be based at either of AstraZeneca’s vibrant R&D and Production sites in, Cambridge (UK), Macclesfield (UK), Gaithersburg (US), Waltham (US), Södertälje (Sweden), or Gothenburg (Sweden)

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Where can I find out more?

AstraZeneca: https://www.astrazeneca.com/

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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

10001196 F RGPD R&D Oncology (Susan Galbraith (07016555)) (85008610)

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.