CMC Regulatory Affairs Associate Director Devices & Digital Therapeutics

AstraZeneca UK

Location: Cheshire East, Gaithersburg, Maryland

Job Type: Full time

Posted

Be brave, not perfect.
- Reshma Saujani


Do you have expertise in, and a passion for Devices & Digital Therapeutics? Do you want to play your part in gaining approval for our novel work on unmet medical needs? Well then… this could be the role for you!

About AstraZeneca

At AstraZeneca we turn ideas into life changing medicines and strive to continuously meet the unmet needs of patients worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, willing to collaborate, and curious about what science can do, then you’re our kind of person! We are now recruiting a CMC Regulatory Affairs Associate Director Devices & Digital Therapeutics.

Our Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs function delivers expert CMC regulatory input for projects spanning across the product lifecycle and leads the regulatory strategy for the development, manufacturing and testing of all of our medicines. With our expertise we interpret, anticipate and craft global Health Authority expectations to build CMC and Device Regulatory Strategies.

What You’ll do
As an Associate Director within Devices & Digital Therapeutics you will represent Device Regulatory as required in cross-functional teams across the business for example Pharmaceutical Development Project teams, Global Regulatory Strategy Teams, Clinical Supply Chain/Global Supply Teams. In this role you will contribute to the development of new guidance, policy, and processes and acts as key contact for identified customer functions to facilitate high quality partnerships within and to some extent external to AstraZeneca. You will also collaborate with other Project Leads/disciplines to support key activities on complex projects by having effective levels of interactive communication within the project team and directly advising and influencing those within the team.

In this role you have the opportunity to contribute to and lead device regulatory components of business-related projects across the life cycle including clinical development/new chemical entities /line extensions/CMC post-marketing management for synthetics and/or biologic products where appropriate. You will be expected to manage risk using evaluative judgements in complicated or novel situations and ensure the application of global device regulations and guidance within AstraZeneca.

In addition you will:

  • Represent Device Regulatory as required on cross-functional teams across the business, such as Pharmaceutical Development Project teams, Global Regulatory Strategy Teams, Clinical Supply Chain/Global Supply Teams.
  • Provide operational, tactical, and strategic device regulatory expertise and direction for submissions across the lifecycle of a product.
  • Manage the provision of expert device regulatory strategic guidance in support of operational initiatives, for example complex/accelerated projects and/or post approval changes
  • Facilitate/support device related interactions with Health Authorities globally.
  • Contribute to knowledge sharing within CMC RA and wider business functions.
  • Manage and communicate high level risk by making complex judgments, developing innovative solutions including proactive risk management and mitigation.
  • Provide AZ technical functions clear, concise guidance on current device regulatory requirements to support business tactical strategic planning. Provide expert recommendation and decisions on regulatory issues relating to devices.
  • Support the implementation of agile and novel approaches in device regulatory submissions that drive new ways of thinking to enhance flexibility and efficiency.
  • Contribute to cross SET non-drug projects and act as business owner for business processes to ensure accelerated submissions, support launch activities/management of regulatory information and ensure regulatory compliance on behalf of AZ.

Doing this we are looking for you that have the appropriate level of Device Regulatory Strategy, Operational, tactical, and decision-making expertise for projects and complex product ranges from development phase through to global launch and post approval lifecycle management.

Essential for the role

  • Degree /PhD or equivalent professional qualification in a science or technical field such as engineering, pharmacy, biology, chemistry or biological science.

  • 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). Other relevant experience in the biopharmaceutical industry considered.

  • Stakeholder & Project management

Desirable for the role

  • Post graduate qualification

  • Business, financial and supply chain understanding/ awareness

  • Demonstrated practical experience in medical device regulatory affairs [e.g. IDE/510(k)/PMA filings; application of device quality management system, software validation, human factors, and design verification/validation requirements

  • Experience of regulatory health authority interactions, inspections and/or external advocacy/regulatory policy

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

So, what’s next?

Are you already envisioning yourself joining our team? Good, because we can’t wait to hear from you! Please apply no later than 30th of September 2022.

Date Posted

07-sep.-2022

Closing Date

06-sep.-2022

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.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

You’ve got this!