CMC Regulatory Affairs Associate

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

QRIOS Life Science is now looking for a CMC Regulatory Affairs Associate for a consulting assignment at AstraZeneca in Södertälje.

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 through to divestment.


About the position
Being a CMC RA Associate within the CMC RA Business Development Team means you are responsible for providing support to Chemistry, Manufacturing and Control (CMC) regulatory contributions required for the management of Product Divestments to 3rd Party Customers. Part of a dynamic team that works closely with both relevant AZ stakeholders and Customers providing regulatory and compliance advice/information as appropriate to ensure compliant supply of product to Customers. The role holder will ensure, where appropriate, the application of global CMC regulations and guidance within AstraZeneca to support Customer interactions and contribute to updates of processes as appropriate.

Responsibilities
• As necessary, assist in the preparation of regulatory submissions, compilation of submission documentation, and preparation of regulatory components in line with Customer requirements/timelines and management of information.
• Responsible for upload, retrieval, and maintenance of documents for electronic submissions using the appropriate software and applications.
• As necessary, ensure maintenance and filing of regulatory related documentation and track regulatory commitments, submission requests, and deliverables to facilitate efficient transfer of registered information to the 3rd Party Customer.
• The role holder will train, guide and advise others, develop training and user support materials, e.g. job aids, work instructions, training videos, e-learning
• Business administration of systems, e.g. provision of system access, application of security models and managing change.
• Interact with cross-functional groups and attend team meetings as necessary to support submission development and project coordination.
• Assist in the preparation of agendas, presentations, and other supporting materials for various meetings.
• Contribute to the development and improvement of related business processes.
• Ensure the learning from own projects are shared with other colleagues/within the functions.

Your profile
Essential for the role:
• Foundational / Associate degree in Regulatory Sciences, Pharmacy, or Pharmaceutical Sciences
• Team working skills
• IT Skills
• Experience in Regulatory Affairs or Quality Assurance.

Desirable for the role:
• Bachelors degree in Science, Regulatory Sciences, Pharmacy, Pharmaceutical Sciences
• Basic Knowledge of the regulatory submissions process.
• Understanding of current regulatory CMC requirements.
• Basic Understanding of regulations and guidance governing the manufacture of biotechnology products, · Professional Capabilities - Lean Approach
• Quality Risk Management


About the organisation
QRIOS Life Science can offer several opportunities for skilled people with a background in biochemistry, chemical engineering or science. We work with Sweden’s leading pharmaceutical and life science companies. So whether you’re interested in research, regulatory affairs, quality assurance, environmental and quality control, sales and marketing, or just want a career change, we have the job for you.

Working as a consultant suits whoever wants to get a lot of experience in a short period of time. We offer you the chance to work with well-known brands at renowned companies where you can develop your skills. If you’re looking for a world of exciting assignments and new contacts, you’ll like being a consultant.

About Astra Zeneca:
AstraZeneca is a major international healthcare company engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. But we are more than one of the world’s leading pharmaceutical companies - at AstraZeneca, we are proud to have a unique 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.