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Regulatory Chemistry, Manufacturing, and Controls Associate Director

Местоположение Macclesfield, Англия, Великобритания Гейтерсберг, Мэриленд, США Идентификатор вакансии R-102949 Дата публикации 03/16/2021

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

At AstraZeneca, we’re not afraid to do things differently. Adapting to the global pharmaceutical landscape we’re meeting the challenges faced head-on; applying new ways of working and bringing excellent teams together to deliver against patients’ needs. The result is a vibrant and thriving organisation that is positioned to succeed in all that we do.

Build unrivalled capabilities in a place that promotes learning agility and offers development opportunities. We never stand still so you’ll have the chance to constantly grow your abilities, skills and knowledge. Here we are a fusion of challenging and interesting work, in an energising and inspiring environment.

Embrace the opportunity for development – whether that’s upskilling or reskilling. We are reimagining what a culture of lifelong learning means. Because we want all our people to embrace the challenges and opportunities that lie ahead. This is the place to build a long-term career.

We are looking for a Regulatory Chemistry, Manufacturing and Controls (CMC) Associate Director to join the Operations Regulatory department on a permanent basis.

Role Responsibilities

As a Regulatory CMC Associate Director, you will:

  • Working with Reg CMC Product Leads, proactively partner with global project teams and stakeholders across the AZ organisation 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).  
  • Maximise 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 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 optimise the proposed submission content.  
  • Ensure organisational 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).

Key Skills & Knowledge

  • Experienced graduate or PhD in a scientific discipline e.g. chemistry, pharmacy or biological science
  • 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 focussed mindset.
  • 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

Competitive salary and benefits package on offer

Date Posted: 16-Mar-2021

Closing Date: 03-May-2021

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 authorisation and employment eligibility verification requirements.

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