CMC-RA Associate II
Job Title: CMC RA Associate II
Introduction to role:
Are you ready to make a significant impact in the world of Chemistry, Manufacturing, and Control (CMC) documentation? As a CMC RA Associate II, you'll be at the forefront of supporting submissions for both original marketing applications and the maintenance of existing licenses for marketed products. Join a dynamic team that collaborates closely with product and project teams, providing essential regulatory and compliance advice. Your role will ensure the application of global CMC regulations and guidance, driving innovation and excellence in the field.
Accountabilities:
- Assist and manage (as applicable) in the preparation of regulatory submissions, including formatting and compilation of submission documentation, and preparation of regulatory components.
- Support and deliver submission-ready packages to agreed timelines and manage information requirements.
- Responsible for upload, retrieval, and maintenance of documents for electronic submissions using appropriate software and applications.
- Ensure maintenance and filing of regulatory-related documentation and track regulatory commitments, submission requests, and deliverables.
- Develop research skills relevant to information, regulations, and guidance from different regulatory agencies.
- 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.
- Give to the development and improvement of related business processes.
- Review submission documentation for accuracy and compliance with applicable regulations and guidelines as required.
- Share takeaways from own projects with colleagues/within functions.
- Conduct activities and interactions consistent with Things We Value and in compliance with the Code of Ethics and supporting Policies and Standards relevant to your role (including SHE). Complete all required training on the AZ Code of Ethics and supporting Policies and Standards on time. Report potential issues of non-compliance.
- Drive business performance through continuous improvement by following processes, identifying problems, solving them, and implementing improvements.
Essential Skills/Experience:
- Educated to degree level/equivalent experience in a scientific field e.g., chemistry, pharmacy or biological science
- Minimum 7 years of relevant experience from biopharmaceutical industry, or other relevant experience
- Team working skills
- IT Skills
- Self-motivated
- Professional capabilities: Regulatory knowledge
Desirable Skills/Experience:
- Basic knowledge of the drug development process and regulatory submissions
- Understanding of current regulatory CMC requirements
- Experience in pharmaceutical production, regulatory affairs, quality assurance, R&D
- Basic understanding of regulations and guidance governing the manufacture of biotechnology products, especially monoclonal antibodies
- Professional capabilities: Lean Approach, Quality Risk Management
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives 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.
AstraZeneca is where science meets innovation! Join a team dedicated to pioneering new frontiers in Oncology with a vision to eliminate cancer as a cause of death. With pioneering science fused with the latest technology, we aim to deliver breakthroughs backed by investment. Our collaborative research environment unites academia and industry, expediting research in some of the hardest-to-treat cancers. Be empowered to lead at every level, take smart risks, and contribute to improving millions of lives.
Ready to make bold moves? Apply now to join our ambitious journey!
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 authorisation and employment eligibility verification requirements.
