International CMC Regulatory Affairs Associate
Location: Cheshire East
Job Type: Full time
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.
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.
What you will do :
The CMC RA Associate is responsible for providing support in the collection, evaluation, preparation, assembly and publishing of Chemistry, Manufacturing and Control (CMC) regulatory contributions required for marketing or post-approval submissions. Part of the international CMC team that works closely with relevant product and project teams providing regulatory and compliance advice as appropriate for the international region. The role holder will ensure the application of international CMC regulations and guidance within AstraZeneca and contribute to updates of policy and processes as appropriate.
- Assist in the preparation of international regulatory submissions, including formatting and compilation of submission documentation, and preparation of regulatory components.
- Ensure that publishing tools are in place and to perform publishing of the CMC sections in a timely manner.
- Support and delivery of submission ready packages to agreed timelines and management of information required.
- Responsible for upload, retrieval, and maintenance of documents for electronic submissions using the appropriate software and applications.
- Ensure maintenance and filing of regulatory related documentation and track regulatory commitments, submission requests, and deliverables.
- Develop research skills relevant information, regulations, and guidance from different regulatory agencies.
- The role holder will train, guide and advise others, develop training and user support materials, e.g. job aids, training videos, e-learning
- Writing scripts and participating in system testing in support of system releases
- 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.
- Review submission documentation for accuracy and compliance with applicable regulations and guidelines as required.
- Ensure the learning from own projects are shared with other colleagues/within the functions.
- Foundational / Associate degree in Science, Regulatory Sciences or Pharmacy
- Team working skills
- IT Skills
- Professional capabilities: Regulatory knowledge
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.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.