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Regulatory Affairs Manager

2 months ago

Newcastle upon Tyne, United Kingdom AstraZeneca Full time

Location – Remote, UK

Outside IR35

Duration – 12 months



Make a meaningful difference at AstraZeneca

Bring out the best in each other, and yourself, by working together as one.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give 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 unique and ambitious world.


​At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.


As a CMC Regulatory Affairs Manager, you will manage the production of Chemistry, Manufacturing and Control (CMC) documentation for designated product ranges. You will manage global CMC regulatory submissions ensuring that project activities and documentation are delivered to the required standards across the product lifecycle including keeping business wide electronic systems up to date to maintain regulatory status.


Duties:


  • Manage the timely preparation (may include authoring) and delivery of CMC contributions to the regulatory submissions linked to medicinal products throughout the lifecycle; including clinical programs, marketing authorisation applications and all post approval approval activities
  • Accountable for delivering “submission ready” CMC modules to internal and external regulatory stakeholders in compliance with relevant AstraZeneca systems and procedures and ensuring submission quality.
  • Ensure that publishing tools are in place and to perform publishing of the CMC sections in a timely manner.
  • Documenting maintenance and communication of Health Authority approval status
  • Provides expertise in regional regulatory requirements to ensure assurance of compliance of CMC submissions.
  • Project management expertise with the ability to adapt to changing situations to ensure on time delivery.
  • Proactively share learning from own projects with other colleagues
  • Where applicable, act as Subject Matter Expert (SME) contributing to and advising project teams.
  • Supporting the agreed strategy to employ fit for purpose content applying regulatory intelligence and to optimise proposed submission content


Minimum Requirements:

  • Degree in Chemistry, Pharmacy or Chemical Engineering, or equivalent experience
  • Fluently spoken and written English
  • Experience in CMC Regulatory Affairs within pharma industry of at least 5+ years
  • Experience in Post approval variations and MAAs is key


We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, colour, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.

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.