Remote Regulatory affairs Jobs • Regulatory Affairs

The Associate Director, Regulatory Affairs Devices and Combination Products works with internal and external partners to deliver products to patients, supporting regulatory objectives for the company’s development and marketed device/combination products, including coordination and management of device global submissions. This position focuses on eye care devices and next generational eye care medicinal delivery products.

This role supports data mapping of eCTD metadata from our legacy publishing system into our future state system and supporting activities in preparation of enabling eCTD 4.0 submissions. The project work will mostly be conducted in Excel, working against data extracts from Veeva Vault RIM and requires a deep understanding of eCTD structure, metadata and organization as well as experience with Veeva Vault RIM.

The Manager, Regulatory CMC is responsible for supporting Chemistry, Manufacturing, and Controls (CMC) regulatory activities related to the development and commercialization of the company’s product. This role works closely with cross-functional teams, including Manufacturing, Quality Assurance, Quality Control, and Research, to compile and maintain high-quality regulatory submissions. The Manager will assist in the preparation of CMC content for INDs/CTAs and amendments, assess change controls for regulatory impact, and help ensure compliance with applicable US and global regulatory requirements.