• Job Description

  Req#: R-205222

  CMC Regulatory Affairs Director, Device Submissions Lead

  Location: Macclesfield (UK)

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

  About AstraZeneca

  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.

  Chemistry, Manufacturing and Controls Regulatory Affairs (CMC RA)

  Our Chemistry, Manufacturing, and Control Regulatory Affairs (CMC RA) function spans across the product lifecycle and is responsible for the regulatory strategy relating to the development, manufacture and testing of all of our medicines.

  With our expertise we interpret, anticipate and craft global Health Authority expectations to build 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 product lifecycle; including Clinical Trial Applications (CTAs), Marketing Authorisation Applications (MAAs) and all post approval activities improving the reliability and value of business critical Supply Chain changes to the AZ organization by supplying the regulatory context, intelligence and mentorship for robust approval and change management.

  Introduction to role:

  Join us at AstraZeneca as a CMC Regulatory Affairs Director, Device Submissions Lead. In this role, you will provide strategic, operational, and tactical expertise related to device submissions from development phase through to global launch and post-approval lifecycle management. You will represent Device Regulatory across the business and lead in the development of device guidance, policy, and processes. This is your chance to challenge others to make our rich pipeline a reality and drive the right approvals for AstraZeneca to realise our ever-expanding pipeline.

  Accountabilities:

  As a CMC Regulatory Affairs Director, Device Submissions Lead you will conduct activities and interactions consistent with What We Value and in compliance with the Code of Ethics. You will provide device regulatory expertise to enable AZ to make device regulatory submissions and collaborate with internal partners to drive cross-functional strategic improvements to the device submissions process. You will also lead device submissions knowledge sharing, coaching, mentoring, and guidance both within CMC RA and wider business functions to foster growth and development within the organisation.

  Essential Skills/Experience:

  • Bachelor’s degree or equivalent experience in Science, Regulatory Sciences or Pharmacy.
  • Extensive experience in Regulatory/Drug development (Industry or Health Authority)
  • Significant experience in the combination product or medical device industry
  • Proven experience in regulatory affairs with a focus on combination products and medical devices (including knowledge of electronic/software-based devices).
  • Demonstrated practical experience in medical device regulatory affairs
  • Experience of regulatory health authority interactions, inspections and/or external advocacy/regulatory policy
  • Customer & Project management
  • Professional capabilities: Regulatory knowledge

  Desirable:

  • Masters' degree or PhD or equivalent experience in Science, Regulatory Sciences or Pharmacy.
  • Business, financial and supply chain understanding/ awareness
  • Understanding of regulations and guidance governing the manufacture of Medical Devices and Combination Products
  • Experience of regulatory health authority interactions, inspections and/or external advocacy/regulatory policy.

  When we put unexpected teams in the same room, we unleash ambitious thinking with the power to encourage life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our outstanding and ambitious world.

  So, what’s next?

  Are you already imagining yourself in this position? Good, because we can’t wait to hear from you!

  The successful candidate will have access to a flexible employee benefits fund, including holiday purchase and flexible time off, pension contributions, Share Save plans, A performance recognition scheme and a competitive, generous remuneration package.

  Applications to be received no later than Thursday 1st August

  Where can I find out more?

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  Date Posted

  18-Jul-2024

  Closing Date

  01-Aug-2024

  Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

• About the company

  AstraZeneca PLC is a British-Swedish multinational pharmaceutical and biopharmaceutical company with its global headquarters in Cambridge, England.

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