Manager RA Publishing & Submissions

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

Purpose and Scope:

Responsibilities include managing the planning, preparation, submission and tracking of correspondence, applications and other structured data to regulatory agencies; identifying and ensuring adherence to relevant submission standards; and interacting with key personnel within the global RAPV organization to resolve procedural and operational complexities.

The position also involves execution-focused interactions with regional health authorities and other Astellas functions such as Marketing Operations, Data Science, Supply Chain, Manufacturing and other areas within Research & Development.

Responsibilities and Accountabilities:

Understands how industry specifications/initiatives impact our processes and deliverables

Trains other staff members on systems and processes

Provides interpretive analyses of complex regulatory guidance documents, regulations, or directives that impact products and operations; advises personnel within RAPV regarding their applicability and impact

Conducts trainings for new users in relevant systems and creates job ides and other documentation on our systems and processes

May assist with certain business system support tasks for key systems including user and functional requirement definition, end user testing and technical infrastructure requirements

May supervise external staff in the conduct of their duties

Manages the planning, preparation, delivery and archiving of published submissions to regulatory agencies around the globe, commonly focusing on specific geographies

Ensures adherence to relevant submission standards, regulatory pathways and regulatory strategies to facilitate efficiency of agency review

Supports submission activities for affiliates and business partners around the globe, commonly focusing on specific geographies

Executes processes to promote electronic document and submission quality control

Maintains strong working relationships with RAPV, members of Project Management and publishing vendors to set submission timelines and content plans

Manages timely internal communication regarding regulatory filing status and other operational information related to assigned products

May represent RAPV Operations on various project teams / task forces as a subject matter expert in the field of electronic document management, submissions management and dossier publishing

May represent the Astellas Publishing & Submission function in meetings with regulatory authorities, usually in conjunction with other RA staff