CMC Regulatory Affairs Consultant
This job is no longer available
There are still lots of open positions. Let's find the one that's right for you.
About The Position
The CMC Regulatory Affairs Consultant will play a pivotal role in providing regulatory strategies that support the clinical development and marketing approval of investigational products. This position involves leading the preparation and maintenance of the Chemistry, Manufacturing, and Controls (CMC) and quality sections for various regulatory submissions, including the initial submission of Investigational New Drug (IND), Investigational Medicinal Product Dossier (IMPD)/Clinical Trial Application (CTA), New Drug Application (NDA), Marketing Authorization Application (MAA), and amendments to Health Authorities (HAs). The consultant will also be responsible for preparing responses to queries from HAs, ensuring that all applicable regulatory requirements are met throughout the product lifecycle. As the CMC regulatory representative on project teams, the consultant will provide essential regulatory support for the clinical development of investigational products. This includes collaborating with the corporate regulatory team, CMC Subject Matter Experts (SMEs), and Contract Research Organizations (CROs) to identify regional and country-specific CMC requirements that support global applications. The consultant will drive CMC submission timelines to align with business objectives and provide regulatory assessment and guidance on CMC-related change controls, deviations, and investigations. The role requires maintaining a comprehensive understanding of the global competitive landscape, regulatory environment, and CMC guidance. The consultant will interpret these regulations for internal stakeholders, ensuring that the organization remains compliant and informed about current industry practices. This position is critical for ensuring that the company meets its regulatory obligations while advancing its product development goals.
