Regulatory Associate II - (CMC DEV) Remote

**Purpose and Scope** Under supervision, assist in all functions pertaining to domestic and international regulatory submissions, including preparation of documents for electronic or paper filing for drug projects. This includes working on project teams to guide development to meet regulatory registration requirements. **Essential Duties \& Responsibilities** * Represent and serve as regulatory representative in project team meetings with consultation. Offer regulatory opinions with consultation from regulatory management. * Assist regulatory management and team with tracking and driving timelines * Review and approve all controlled documents with minimal mentorship. * Create and review routine submission documentation with minimal mentorship. * Coordinate with personnel from other departments to obtain data/documentation for submissions with guidance from the manager. * Review new and existing procedures with mentorship. * Keep current with global health authority regulations/guidelines. * Conform to regulatory department standards and compliance with GMP. * Perform various other duties as assigned. **Knowledge, Skills \& Abilities** * Proficient knowledge of word processing, specifically MS Office Suite, and Adobe Reader/Writer. * Knowledge of Database Management software. * Excellent writing and organizational skills. * Ability to coordinate information from various internal and external disciplines. * Ability to understand regulatory and technical concepts and requirements. * Ability to perform multiple tasks on several projects. * Ability to prepare written summaries of technical data suitable for inclusion in regulatory submissions. * Ability to understand, and comply with domestic and international regulatory requirements. * Ability to follow specific directions and to request instructions for complex tasks. **Core Values** This position is expected to operate within the framework of Tolmar’s Core Values: * **Center on People:** We commit to support the well‑being of our patients and treat our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together with an enterprise‑wide mindset that lifts the whole organization. * **Are Proactive \& Agile:** We embody a culture of engagement and action. With a hands\-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes. * **Act Ethically:** We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion \& sustainability in our workplace. * **Constantly Improve:** We are committed to a proactive, collaborative effort to enhance our products, systems, processes, and services by reducing waste, increasing efficiency, and improvin