AstraZeneca, CMC Regulatory Manager - KellyOCG
KellyOCG Sweden AB / Kemiingenjörsjobb / Södertälje
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hela Sverige KellyOCG are now looking for a CMC Regulatory Affair Manager, for a year long contract with our partner AstraZeneca, who will lead and manage the production of Chemistry, Manufacturing, and Control (CMC) documentation for a range of innovative products.
As a CMC RA Reg Manager, you will oversee global CMC regulatory submissions, ensuring that all project activities and documentation meet the highest standards throughout the product lifecycle. You will play a crucial role in contributing to and leading the regulatory CMC components of business-related projects. Effective communication with stakeholders and project team members will be key to ensuring timelines and regulatory commitments are met.
You will work at AstraZeneca's location in Gärtuna, were you will also have your manager - but you will be hired by KellyOCG who will be your employer in your contract. We will also help you with possible extensions or an eventual transfer over to AstraZeneca full time after your contract.
Accountabilities
• Manage the timely preparation (may include authoring) and delivery of CMC contributions to regulatory submissions linked to medicinal products throughout the lifecycle, including clinical programs, marketing authorization applications, and all post-approval activities.
• Deliver "submission ready" CMC modules to internal and external regulatory stakeholders in compliance with relevant AstraZeneca systems and procedures, ensuring submission quality.
• Ensure that publishing tools are in place and perform publishing of the CMC sections in a timely manner.
• Lead/represent PT&D and Pharm Sci on cross-functional work streams.
• Document maintenance and communication of Health Authority approval status.
• Develop and build expertise in regional regulatory requirements to ensure compliance of CMC submissions.
• Adapt to changing situations to ensure on-time delivery through project management expertise.
• Proactively share learning from own projects with colleagues.
• Act as Subject Matter Expert (SME) or Sub-Process Owner (SPO) contributing to and advising project teams where applicable.
• Provide advice, training, and mentorship to other team members.
• Manage change requests (Veeva), escalate, and input into the cross-functional vote.
• Support the agreed strategy to employ fit-for-purpose content applying regulatory intelligence to optimize proposed submission content.
• Participate in regulatory execution and delivery meetings, providing relevant updates to the CMC team.
• Contribute to business process optimization activities to reduce waste and ensure efficiency.
• Continually evolve and develop regulatory expertise through proactive recording and communication of Health Authority interactions, responses, and commitments.
• Apply GxP principles according to the stage of the product lifecycle.
• Responsible for change management as assigned.
• Understand application of appropriate risk management across own activities.
• Demonstrate research skills in understanding regulations and guidance from different regulatory agencies.
Essential Skills/Experience
• Bachelors degree in Science or technical field such as pharmacy, biology, chemistry or biological science.
• IT Skills
• Stakeholder & Project management
• Professional capabilities: Regulatory knowledge
Desirable Skills/Experience
• Masters degree in Science or technical field such as pharmacy, biology, chemistry or biological science.
• Direct Regulatory Affairs CMC experience with submissions for Biologic and biotechnology derived products such as monoclonal antibodies or complex biologic products
• Knowledge of the drug development process and regulatory submissions
• Understanding of current regulatory CMC requirements
• Understanding of regulations and guidance governing the manufacture of biotechnology products
• Lean capabilities
Interested?
Final date to apply is May 7th, but if you're interested - don't wait to apply, we continually reach out to applicants and may proceed with the recruitment before the last application date.
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.
Så ansöker du Sista dag att ansöka är 2025-05-17
Klicka på denna länk för att göra din ansökan Omfattning Detta är ett heltidsjobb.
Arbetsgivare KellyOCG Sweden AB (org.nr 559407-1622)
Arbetsplats AstraZeneca / KellyOCG Sweden AB
Jobbnummer 9320490
Observera att sista ansökningsdag har passerat.