Associate Director CMC, Regulatory Affairs (Biologics)

AstraZeneca UK

Location: Cambridgeshire, Cheshire East, Gaithersburg, Maryland, South San Francisco, California

Job Type: Full time

Posted

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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 encouraged and valued. An environment that champions inclusion, and teams that reflect the diversity of the communities that we serve.

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 redefining 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.

We are looking for a Associate Director, Regulatory CMC, Biologics to join us in either of AstraZeneca's vibrant R&D sites in Gothenburg (Sweden), Cambridge (UK), Macclesfield (UK), South San Francisco (US), Waltham MA (US), Warsaw Poland, Mississauga Canada or Gaithersburg MD (US). This role will support the biologic technical area, encompassing both well-characterized therapeutic proteins and novel molecules.

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 build insightful CMC and Device Regulatory Strategies in Early and Late.

  • We are the link 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 handle 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 improving the value of business critical Supply Chain changes to the AZ organization by supplying the regulatory context, intelligence and guidance required to advise the development of robust plans for change initiatives.

What You'll Do

  • Working with CMC-RA Product Leads, proactively partner with global project teams and stakeholders across the AZ organization to help build and implement innovative, risk based Regulatory strategies that support multiple medicinal products.

  • 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 (license renewals, Annual reports etc).

  • Improve the value of business critical Supply Chain changes to the AZ organization by supplying the regulatory context, intelligence and guidance required to advise the development of robust plans for the change initiatives.

  • Project manage global CMC regulatory submissions; ensuring that project activities and documentation are delivered to the required high standard, agreed timelines and meet the business requirements, compliance requirements linked to product manufacture and the expectations of health authorities globally.

  • Eliminate unnecessary future regulatory maintenance activities by supporting the strategy to employ fit for purpose content in CMC submissions; applying regulatory intelligence and understanding to critically review and optimize the proposed submission content.

  • Ensure organizational compliance with the registered dossier content through the maintenance and communication of Health Authority approval status for the associated CMC regulatory submissions (MAAs, License Renewals. Annual Reports and post approval changes).

  • Continually evolve and develop the regulatory expertise of the department through the proactive recording and communication of the insights gained during health authority interactions (including from Health Authority information requests).

Minimum Qualifications:

  • Bachelor's degree in a scientific discipline. Advanced degree preferred.

  • 4 years of experience in the pharmaceutical, or a closely related, industry; for example within a Production, Regulatory Affairs, Quality Assurance or R&D function.

  • An appreciation of the science and technology associated with pharmaceutical manufacture, with an awareness of the key regulatory CMC requirements, expectations and principles.

  • Excellent communication (written and spoken) with effective IT skills and a team focused mindset.

Preferred Qualifications:

  • Project management experience with the ability to adapt to changing situations in order to ensure timely delivery.

  • Awareness of, or experience applying, professional capabilities such as Lean, End to End Supply Chain principles, Quality & Compliance Management and Quality Risk Management

Working at AstraZeneca

Here you’ll have the chance to create a substantial difference to patients’ lives! With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines – for the world’s most complex diseases. Answer unmet medical needs by pioneering the next wave of science, focusing on outcomes and crafting the patient ecosystem.

Next Steps? Apply now!

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.

Find out more and follow AstraZeneca on:

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Date Posted

01-Sep-2022

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.

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

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