Manager, Regulatory Operations

Bachelor’s degree in Pharmaceutical, Biological or related field (Master’s preferred). Minimum of 4+ years’ overall experience in the biopharmaceutical/biotech industry. Minimum of 3+ years of direct experience with publishing regulatory submissions. Strong hands-on working experience with Veeva RIM systems. Proven expertise in electronic submission processes (eCTD) and global regulatory requirements. Experience with eCTD publishing tools (e.g., Veeva Publisher, docuBridge, OmniFile, etc.). Experience with domestic/global submission gateways and portals. Demonstrated knowledge of best practices in Veeva RIM, Veeva PromoMats, Veeva eTMF, MS Word, Excel and Adobe Acrobat. Ability to effectively multi-task and work under tight deadlines. Excellent organizational skills. Excellent communication and interpersonal skills. Self-motivated with eagerness to grow professionally and learn. Ability to interpret and implement complex regulatory legislation and/or updates.

Manage coordination and publishing of submissions to regulatory Health Authorities in eCTD format using Veeva RIM. Monitor submission timelines and identify risks/delays using Veeva RIM. Provide training and guidance to regulatory staff on Veeva RIM. Implement and optimize Veeva RIM workflows for efficiency. Maintain accurate, audit-ready records and metadata within Veeva RIM. Process submission objects and content plans within Veeva RIM. Archive regulatory submissions and correspondences. Collaborate with QA, IT, and 3rd parties on Veeva RIM system configurations. Maintain regulatory chronologies and trackers. Maintain knowledge of electronic submission regulations and standards. Support development of standard operational procedures and systems. Coordinate with external partners for operational deliverables. Manage and resolve publishing-related issues. Maintain regulatory submission tracking reports. Maintain clinical trial regulatory compliance tracking. Establish and maintain the regulatory archive in the eTMF Veeva Vault structure. Support a work environment focused on quality, learning, and collaboration.