* We are seeking an experienced Regulatory Affairs CMC Consultant with over 10 years of expertise in Chemistry, Manufacturing, and Controls (CMC) within the pharmaceutical or biotech industry.
* The ideal candidate will have strong hands-on experience in CMC dossier preparation, lifecycle management, regulatory submissions (IND, NDA, MAA), and global health authority interactions.
* Proven experience working with Veeva RIM for regulatory information management, submission publishing, document management, and tracking is essential.
* The consultant will support regulatory strategy, ensure compliance with global guidelines (FDA, EMA, ICH), manage variations and post-approval changes, and collaborate cross-functionally with Quality, Manufacturing, and Clinical teams.
* Strong knowledge of eCTD submissions and regulatory documentation processes is required.
Key Skills: CMC Regulatory Affairs, Veeva RIM, eCTD, Global Submissions, Regulatory Strategy, Lifecycle Management, ICH Guidelines.
#J-18808-Ljbffr