Work from Office
Full Time
We are hiring Regulatory Associates and Specialists with 2 to 8 years of relevant pharmaceutical ( with finished formulations/OSD) experience to manage the compilation and submission of documents to global markets, including the EU, UK, New Zealand, CIS, GCC, ASEAN, and LATAM.
Associates will gain experience by compiling and coordinating with the team on projects and regulatory submissions, gathering documents in accordance with the regulatory requirements for the markets mentioned. Responsibilities include compiling new application and lifecycle management CTD dossier modules, and interpreting and preparing responses to quality and administrative deficiencies in accordance with regulatory guidelines within defined timelines. Additionally, you will develop and implement regulatory strategies to support new Marketing Authorization Applications, post-approval changes, variations, and lifecycle activities. This role also involves coordinating with cross-functional teams to request, review, and prepare documentation necessary for regulatory submissions, and ensuring that all documentation is thoroughly reviewed prior to submission.
Medreich
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