CMC Regulatory Affairs Director

Are you passionate about the application of science to deliver life changing medicines?

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

We are looking for a Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs Director to join us on a permanent basis in either the UK, US or Swe.

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 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.

What you'll do

* Proactively lead complex projects for new biologic or other modality, or line extensions and post approval submissions, as a representative of CMC-RA, helping to build innovative, risk based Regulatory strategies. Will lead and/or deliver regulatory CMC components of business related projects across functions
* Provide progressive strategic, tactical or operational, regulatory CMC expertise and direction to AstraZeneca Global project teams
* Establish effective networks with marketing companies, manufacturing sites and relevant technical functions such as Development, Operations or Quality as appropriate for assigned projects. May act as key contact for identified customer functions to facilitate high quality partnerships
* Lead high level risk by looking at regulatory options and making complex judgements, developing innovative risk based solutions and applying progressive comprehensive cross-functional and industry understanding
* Ensure the awareness of global CMC regulations and guidance exists within AstraZeneca, to enable development of scientific and regulatory strategies to negotiate with Agencies and develop fit for purpose global submissions

Essential for the role

* Experienced graduate or PhD in a scientific discipline, typically chemistry, pharmacy or a biological science
* A significant knowledge and understanding of the science and technology associated with pharmaceutical development and manufacture, and aware of advances in Agency thinking in these areas
* Experienced 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
* Previously contributed to at least one major regulatory submission in the global environment
* Significant project or line management experience in a relevant environment

Posted: 2021-10-28
Closing: 2021-11-24
Compensation & Benefits: Competitive

Why AstraZeneca?
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 24th November, 2021.

Where can I find out more?
AstraZeneca:https://www.astrazeneca.com/
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