We are currently looking for a consultant to take on an exciting role as a CMC RA Regulatory Manager at AstraZeneca, one of the world's leading pharmaceutical companies. AstraZeneca is a global, innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of prescription medicines that make a real difference in patients' lives. They operate in over 100 countries, and their medicines are used by millions of patients worldwide.
At AstraZeneca, innovation, collaboration, and a passion for science are at the heart of everything they do. Their high-tech environments foster collaboration, entrepreneurial spirit, and smart solutions. Working with them means you will contribute to the delivery of high-quality, sustainable pharmaceutical products — and you will truly make a difference.
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This is a consultant assignment through Randstad Life sciences. At Randstad Life Sciences, we are your employer, but you will work on-site with one of our valued clients. Your dedicated consultant manager will always be close at hand to support you both during and between assignments, helping you develop your career in the direction you aspire to. As a consultant with us, you will enjoy a competitive salary, benefits, and collective agreement conditions. We listen carefully to your wishes regarding assignments and tasks, and with our broad client portfolio in Mälardalen, we will shape your career based on your skills, experience, and ambitions. At Randstad Life Sciences, we also offer opportunities for skills development and/or additional time off after you have been with us for a period. You will be part of a larger consulting team within Life Sciences, giving you the chance to expand your network and gain valuable experience from different workplaces.
Your role
As a CMC RA Regulatory Manager, you will lead and manage the production of Chemistry, Manufacturing, and Control (CMC) documentation for a range of innovative products. Your responsibilities will include managing global CMC regulatory submissions, ensuring that project activities and documentation meet the highest standards across the product lifecycle, and effectively communicating with stakeholders and project team members to meet regulatory timelines and commitments.
Key responsibilities include:
- Preparing and delivering CMC contributions to regulatory submissions across the product lifecycle (clinical, marketing authorization, and post-approval).
- Ensuring “submission-ready” CMC modules in compliance with AstraZeneca standards.
- Managing document publishing tools and performing CMC publishing activities.
- Representing Pharmaceutical Technology and Development (PT&D) and Pharmaceutical Sciences (Pharm Sci) on cross-functional project teams.
- Managing Health Authority approval documentation and status communication.
- Building expertise in regional CMC regulatory requirements.
- Providing training and mentorship to other team members.
- Supporting fit-for-purpose content strategies and regulatory intelligence.
- Engaging in continuous improvement and LEAN initiatives.
You will be working both independently and in collaboration with cross-functional teams, locally and globally. Continuous improvements and LEAN thinking are highly valued and integral to the way we operate, and your active participation is expected.
We believe you have:
- - Bachelors degree in Science or technical field such as pharmacy, biology, chemistry or biological science.
- - IT Skills - regulatory databases e.g. RIM and ERV
- - Stakeholder & Project management
- - Professional capabilities: Regulatory knowledge, clinical and/or commercial
It is an advantage if you also have:
- - 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
Why AstraZeneca?
At AstraZeneca, we foster a workplace that promotes inclusion and diversity. You will be part of a broad network of high-performing teams that care deeply about your well-being, career development, and success. Our clear strategy and growth focus mean there are always new, exciting projects to get involved in.
Learn more about us:
- AstraZeneca Careers Sweden
- A Life-Changing Day – Inside Quality Operations
Additional Information
- This is a consulting assignment via Randstad Life Sciences, with daily work on-site at AstraZeneca.
- All selected candidates must complete a background check, as well as an alcohol and drug test.
Application
Submit your application no later than 7th of May 2025. Selection and interviews will be conducted continuously. Please note that we do not accept applications via email.
