This position will be directly responsible for managing CMC post-approval activities for a biopharmaceutical product approved in US, EU, Japan, and ROW markets. The individual will work collaboratively and proactively within the CMC project team and across multiple functional areas to manage the response activities to develop the strategy, scope, and content of the CMC sections of the responses. The main responsibilities of this position include the following:
• Provide guidance to functional area authors/reviewers with regards to submission and dossier requirements. Understand, interpret, and advise on regulations, guidelines, procedures, and policies relating to the development, manufacture, and successful global registration of biopharmaceutical products.
• Directly manage completion of multiple dossier components to meet project timelines.
• Review documents and dossier components to assure that technical/regulatory strategy and data integrity processes are followed.
• Accountable for ensuring that dossier components meet global/regional standards for content, quality, and regulatory requirements.
• Work closely with project team members and CMC regulatory team to produce high quality submissions.
• Work closely with project management and CMC regulatory team to execute plans for managing workload within assigned project objectives through efficient resource utilization and within designated timeframes. Effectively adjust plans to deal with changes and obstacles.
• Identify, document, and communicate regulatory project risks that could impact timeline and quality of regulatory submissions.
• Organize and archive CMC dossier components and supporting documents in appropriate document management systems.
• Interface with regulatory operations staff to coordinate dossier review, approval and publishing activities.
• Bachelor’s degree in life sciences or related scientific discipline.
• Minimum of 5 years experience in pharmaceutical or biotechnology drug development, with direct involvement in CMC-related activities and functions.
• Experience in authoring CMC content for regulatory submissions is required, preferably with a minimum of 2 years in regulatory affairs or related function.
• Strong technical writing skills and attention to detail.
• Strong verbal communications skills and demonstrated ability to work in a matrix/team environment.
• Ability to effectively plan, prioritize and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines.
• Strong computer skills in Microsoft Office applications with the ability to learn new applications quickly and easily.
• Two (2) or more years of CMC regulatory affairs experience with biopharmaceutical products (e.g., monoclonal antibodies and therapeutic proteins).
o Basic knowledge of FDA and EU CMC regulatory requirements.
o Experience with preparation of CMC submissions (INDs, IMPDs, amendments, BLA/MAA). Ability to track multiple dossier components and manage successful completion of components for submissions. Understanding of dossier development and formatting requirements, document and dossier management.
• Proficiency with Electronic Document Management Systems, preferably Documentum, and publishing tools such as Adobe Acrobat.
• Expert knowledge and hands-on experience in at least one area related to CMC biopharm product development (e.g. analytical or process development, manufacturing, quality control).
All profiles will be reviewed against the required skills and experience. Due to the high number of applications, we will only be able to respond to successful applicants in the first instance. We thank you for your interest and the time taken to apply.