CMC Regulatory Affairs Manager

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

We are looking for a Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs Manager to join us in one of our following sites: Gothenburg (SE) or Södertälje (SE).

Chemistry, Manufacturing, and Controls (CMC)
Our Chemistry, Manufacturing, and Controls (CMC) Regulatory function spans 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.

We are the bridge 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 manage the timely preparation and delivery of CMC contributions to the regulatory submissions linked to medicinal products throughout the commercial lifecycle; including Clinical Trial Applications (CTAs), 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
Being a CMC RA Manager, means that you will effectively manage the production of Chemistry, Manufacturing and Control (CMC) documentation for designated product ranges to deliver the needs of both the AZ business and the customer. You will project manage global CMC regulatory submissions ensuring that project activities and documentation are delivered to the required standards across the product lifecycle.

As a CMC RA Manager you will also contribute and own the regulatory CMC components of business-related projects having effective levels of interactive communication with collaborators and project team members to ensure that relevant timelines and regulatory commitments are communicated. The accountabilities also include responsibility for change management as assigned and to ensure the learning from own projects are shared with other co-workers/within the function.

Responsibilities:

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Be accountable for delivering "submission ready" CMC modules to internal and external regulatory partners in compliance with relevant AstraZeneca systems and procedures, ensuring submission quality
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Manage/Lead the preparation and delivery of CMC contributions throughout the product lifecycle
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Maintain regulatory databases related to submissions
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Communicate Health Authority approval status
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Develop and build expertise in regional regulatory requirements to ensure compliance of CMC submissions
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Support the agreed strategy to employ fit for purpose content, applying regulatory intelligence to optimize proposed submission content
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Participate in regulatory execution and delivery meetings and communicate and provide relevant updates to the CMC team
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Contribute to business process optimization activities to reduce waste and ensure efficiency
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Continually evolve and develop regulatory expertise through proactive recording and communication of Health Authority interactions, responses and commitments
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Apply GxP principles according to the stage of product lifecycle

Essential for the role:

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Bachelor's degree in a scientific subject area or equivalent
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Proven experience of growing documented success in a biopharmaceutical field or related experience in a manufacturing, technical or regulatory environment
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IT Skills
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Stakeholder & Project management
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CMC Regulatory dossier knowledge
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Project management expertise with the ability to adapt to changing situations to ensure on time delivery

Desirable for the role:

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Knowledge of the drug development process and regulatory submissions
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Understanding of current regulatory CMC requirements
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Direct/indirect Regulatory Affairs CMC experience with submissions for synthetics and/or biologic and biotechnology derived products such as monoclonal antibodies or sophisticated biologic products e.g. vaccines or ATMPs
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Understanding of regulations and guidance governing the manufacture of biotechnology products
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Lean capabilities
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Demonstrated research skills in understanding regulations, and guidance from different regulatory agencies
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Understands application of appropriate risk management across own activities

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.

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.

So, what's next?
Are you already imagining yourself joining our team? Good, because we can't wait to hear from you! We will screen applications continuously, please apply as soon as possible but no later than 3 April, 2023.