iCMC Regulatory Affairs Manager
5 days ago
Job Title: iCMC Regulatory Affairs Manager
Career Level - D
Introduction to Role:
Join our Biopharmaceuticals R&D team as an iCMC Regulatory Affairs Manager. This is an exciting opportunity to innovate in a safe environment, where you will be part of a team with deep specialist knowledge and regulatory expertise. We are confident in what we know and what it takes to ideate and innovate towards better solutions. And it's a safe space to do it. From the top, we are empowered to speak up and listen to each other.
Accountabilities:
As an iCMC Regulatory Affairs Manager, you will ensure the application of international CMC regulations and mentorship within AstraZeneca and lead/chip in to the development of new guidance, policy, and processes. You will manage the timely preparation and delivery of CMC contributions to the regulatory submissions linked to medicinal products throughout the lifecycle. This includes marketing authorisation applications and all post-approval activities. You will be accountable for delivering “submission ready” international CMC modules to internal and external regulatory stakeholders in compliance with relevant AstraZeneca systems and procedures, ensuring submission quality.
Essential Skills/Experience:
Bachelors degree in Science, Regulatory Sciences or Pharmacy
Experience in Regulatory / Drug development (Industry or Health Authority)
Breadth of knowledge of manufacturing, project, technical and regulatory management.
IT Skills
Stakeholder & Project management
Professional capabilities: Regulatory knowledge
While not essential, any additional skills or experience in the field would be beneficial.
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire 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 unique and ambitious world.
At AstraZeneca, we are committed to turning our drug development strategies into reality. We work at all stages of development to translate our life-changing science into medicines to get the best results for AstraZeneca, patients in need, and healthcare professionals. We are always looking for someone different to join our efficient and nimble team. If you can offer us some original thinking, a different approach or skillset, then you'll fit in. We are a diverse and open-minded team harnessing our different skills and experiences.
Are you ready to be part of the solution? Are you ready to push beyond the traditional? Are you ready to lead breakthroughs? If so, apply today
Date Posted
10-Jun-2024Closing Date
16-Jun-2024-
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