At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

In our science-led enterprise, there are new, complex and first-in-class products to get to market. We drive fast approvals to play an instrumental role in achieving our aim of getting the right medicines to the right patients, faster than ever before. It’s meaningful to be part of AstraZeneca’s growth and deliver life-changing medicines to patients in areas of unmet medical needs.

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.

AstraZeneca is the place to build a career in Regulatory CMC. Here we inspire and support to help drive your professional and personal growth and development. With a defined career ladder, a recognition culture that celebrates successes and exciting opportunities for those with the drive to achieve. Your development is something we passionately support.

Description:

To proactively partner with Global Regulatory CMC Teams on complex global projects for new biologic or other modality, or line extensions and post approval submissions, helping to build innovative, risk based Regulatory strategies. Will lead and/or deliver regulatory CMC components of business related projects across functions, of high quality, consistent and complete, as agreed for the Product strategies. May provide effective RA CMC representation on a variety of development product teams

Will input to and support progressive strategic, tactical or operational, regulatory CMC expertise and direction to AstraZeneca Global Reg project teams. Will have a high level of interactive communication and support the direction for the team, working flexibly with the team.  Has good understanding of need for cultural sensitivity.

Will support managing high level risk by looking at regulatory options and working with the team to make complex judgements, developing innovative risk based solutions and applying progressive comprehensive cross-functional and industry understanding.

Accountabilities/Responsibilities:

Support regulatory representatives on assigned project teams. Support application of progressive thinking and regulatory CMC expertise to TA and non-TA projects within AZ RA and AZ technical functions and help develop innovative regulatory strategies globally.  Will typically have responsibility for development projects for new biologics, other modalities and post approval product support. Ensure project activities are negotiated and delivered to a high standard, agreed time scales and meet AZ business requirements, compliance requirements and regulatory authority expectations worldwide Project manage to ensure project activities and documentation are delivered to a high standard, agreed time scales and meet AZ business requirements, compliance requirements regarding manufacturing and development and regulatory authority expectations worldwide. Supports the strategy for fit for purpose content of CMC submissions and review and approve regulatory CMC documents on behalf of AZ RA for assigned projects. Such submissions are clinical trial applications (IND, CTA, etc), marketing authorisation applications (NDA, MAA, JNDA etc), line extensions, or post approval activities. The applications may be global in scope. Co-ordinates the delivery of submission documentation which is fit for the intended purpose with appropriate consideration of the desire for subsequent operational and supply flexibility. Plans, coordinates, prepares, and supports meetings with regulatory agencies. Working with the Reg CMC team to provide AZ technical functions clear, concise guidance on current CMC regulatory requirements, as well as creative thinking for alternative Reg. acceptable strategies, to support business tactical or strategic planning. Support recommendations and decisions being proposed on regulatory issues relating to CMC, including risk management and mitigation and communication of these. Participate and/or lead various multi-disciplinary teams or taskforces related to CMC/product development. May lead key business improvement initiatives. Interact effectively with external business partners.  As agreed with Project lead, works with marketing companies, manufacturing sites and relevant technical functions such as BPD, GTO or Quality as appropriate for assigned projects. May act as key contact for identified customer functions to facilitate high quality partnerships with customers. Ensure that the electronic records in internal documentation systems are accurate and complete, e.g. Register, Angel etc. Ensure that own work and training is performed in accordance with appropriate SHE, quality and compliance standards. Carry out main role responsibilities, ensuring compliance with AZ Corporate Responsibility policies, as well as AZ values and beliefs.
 

Minimum Requirements –Education and Experience

• Experienced graduate or in a scientific discipline, typically chemistry, pharmacy or a biological science.
• Knowledge and understanding of the science and technology associated with pharmaceutical development and manufacture
• Experience in Regulatory Affairs, with focus on CMC. Other relevant experience in the pharmaceutical industry, for example in Pharmaceutical or Analytical Development, Quality Control, Manufacture, might also be considered.
• Awareness of regulatory requirements and submissions pathways.
• Significant project or line management experience in a relevant environment.

So, what’s next?

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

Where can I find out more?

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

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Competitive Salary and Benefits

Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.