AstraZeneca contributes meaningfully to the UK beyond the provision of our medicines and the benefits they provide to the health of the nation. We commissioned a report in 2009 to measure our significant investment to the UK economy, which includes investment in jobs and wealth creation. Oxera, an independent economic consultancy provided the analysis for this report.
Post : CMC Regulatory Affairs Associate I
Brief Job Description
The CMC RA Associate is responsible for providing support in the collection, evaluation, preparation, and assembly of Chemistry, Manufacturing and Control (CMC) documentation required for submissions to support both original marketing applications and maintenance of existing licenses for marketed products including post approval submissions. Part of a dynamic team that works closely with relevant product and project teams providing regulatory and compliance advice as appropriate. The role holder will ensure the application of global CMC regulations and guidance within AstraZeneca and contribute to updates of policy and processes as appropriate.
Job Responsibilities (to include key result areas, specific accountabilities, tasks, etc.)
• Assist in the preparation of regulatory submissions, including formatting and compilation of submission documentation, and preparation of regulatory components.
• 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.
• 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.
Typical Accountabilities (per AZ framework and regulatory expectations)
• Conduct activities and interactions consistent with Company Values 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.
• AstraZeneca drives business performance through continuous improvement, we therefore expect all employees to 1)Follow processes and work to standards. 2)Identify and solve problems 3) Define and implement improvements. Leaders will lead by example in creating a learning & continuous improvement culture.
• Educated to degree level /equivalent experience in a scientific discipline eg chemistry, pharmacy or biological science
• Minimum 4 years of Relevant experience from biopharmaceutical industry, or other relevant experience
• Team working skills
• IT Skills
• Professional capabilities: Regulatory knowledge.
• Basic Knowledge of the drug development process and regulatory submissions
• Understanding of current regulatory CMC requirements.
• Experience in Pharmaceutical production , reg 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.
Experience : 4 years
Qualification : M.Pharm, B.Pharm, M.Sc, B.Sc
Location : Bangalore
Industry Type : Pharma
Functional Area : Regulatory Affairs
End Date : 10th August, 2023
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