First-time filing experience: hands-on authoring, review, and submissions for initial filings in the US and EU(e.g., IND, ANDA, NDA, BLA, MAA).2. Health authority queries: hands-on management, including data gathering and drafting of responses.3. Source data review: hands-on review of source data from R&D, manufacturing, and related functions.4. Lifecycle management: demonstrated experience with post-approval lifecycle activities in the US and EU.experienc
First-time filing experience: hands-on authoring, review, and submissions for initial filings in the US and EU(e.g., IND, ANDA, NDA, BLA, MAA).2. Health authority queries: hands-on management, including data gathering and drafting of responses.3. Source data review: hands-on review of source data from R&D, manufacturing, and related functions.4. Lifecycle management: demonstrated experience with post-approval lifecycle activities in the US and EU.experienc
Position OverviewWe are seeking a detail-oriented and experienced Regulatory Affairs Officer to join ourSupply Chain and Logistics team. This is a critical high-priority hire intended to bolsterour compliance department ahead of several major upcoming audits. You will beresponsible for managing certifications, ensuring adherence to internationalmanufacturing standards, and providing mentorship to junior staff as the organizationscales its operations.Key Re
Position OverviewWe are seeking a detail-oriented and experienced Regulatory Affairs Officer to join ourSupply Chain and Logistics team. This is a critical high-priority hire intended to bolsterour compliance department ahead of several major upcoming audits. You will beresponsible for managing certifications, ensuring adherence to internationalmanufacturing standards, and providing mentorship to junior staff as the organizationscales its operations.Key Re