Associate Director - Regulatory Affairs CMC Commercial Biologics
This position will provide Regulatory Affairs CMC strategy and tactical elements of regulatory submissions for approved biologic products. This role will actively partner with regulatory therapeutic area counterparts to establish alignment with product regulatory strategies and to communicate Regulatory Affairs CMC documentation requirements to team members both internally and externally with a focus on lot distribution reports. This manager position is specifically responsible for providing support in the collection, evaluation, preparation, and assembly of documentation required for US and international (ex-US) submissions to support both original marketing applications and maintenance of existing licenses for marketed products.
• Assist in the preparation of regulatory submissions, including formatting and compilation of submission documentation, and preparation of regulatory components (forms, cover letter, etc).
• Assist with the establishment of submission timelines and management of information required to meet submission target dates.
• Responsible for upload, retrieval, and maintenance of documents for electronic submissions using the appropriate software and applications.
• Ensure proper maintenance and filing of regulatory related documentation and track regulatory commitments, submission requests, timelines, and deliverables.
• Research relevant 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.
• Author regulatory SOPs, Guidelines, and Toolkits.
• Provide management updates and project reports as required.
• Assist senior regulatory staff in collating and addressing regulatory submission review comments.
• Review submission documentation for accuracy and compliance with applicable regulations and guidelines as required.
• Support senior regulatory staff in performing regulatory review and evaluation of CMC changes that may impact existing or pending international regulatory files.
• Proactively identify potential issues and alert supervisor for further action.
• BS/MS in a scientific discipline.
• Ability to multi-task; excellent planning and organizational skills with attention to detail and accuracy
• Strong interpersonal and communication (oral and written) skills
• Computer savvy; competent with common computer applications, such as MS Word, Acrobat, PowerPoint, Project, and Excel; and comfortable working with document management and other electronic submission systems
• Self-motivated and require minimum supervision when performing routine job functions
• Eager to learn relevant scientific knowledge and new regulatory requirements
• Experience working with approved biologics is preferred.
• Experience with firstdoc based documentation management systems
• Quality Assurance experience orTechnical experience in the testing or manufacture of biotechnology-derived products or complex biologics.
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.