Manager, RA Publishing & Submissions

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 deliverablesTrains other staff members on systems and processesProvides interpretive analyses of complex regulatory guidance documents, regulations, or directives that impact products and operations; advises personnel within RAPV regarding their applicability and impactConducts trainings for new users in relevant systems and creates job ides and other documentation on our systems and processesMay assist with certain business system support tasks for key systems including user and functional requirement definition, end user testing and technical infrastructure requirementsMay supervise external staff in the conduct of their dutiesManages the planning, preparation, delivery and archiving of published submissions to regulatory agencies around the globe, commonly focusing on specific geographiesEnsures adherence to relevant submission standards, regulatory pathways and regulatory strategies to facilitate efficiency of agency reviewSupports submission activities for affiliates and business partners around the globe, commonly focusing on specific geographiesExecutes processes to promote electronic document and submission quality controlMaintains strong working relationships with RAPV, members of Project Management and publishing vendors to set submission timelines and content plansManages timely internal communication regarding regulatory filing status and other operational information related to assigned productsMay 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 publishingMay represent the Astellas Publishing & Submission function in meetings with regulatory authorities, usually in conjunction with other RA staff

Required Qualifications

Bachelor's degree (science or technology is preferred)At least three years experience in the pharma industry with some experience in a regulatory operations roleDemonstrated accomplishments and/or education will be evaluated and substituted for extent of experience, as neededAbility to work independently with minimal direction and within project teams, committees, etc. to attain group goalProven ability to prioritize and multi-task with minimal supervision based on interactions with project team membersIf managing staff the incumbent should have experience managing people and/or teams or otherwise demonstrate the ability to do soStrong ability to communicate effectively in writing and verbally in EnglishAbility to multi-task across multiple projects and deliverablesHigh integrity to maintain confidential and proprietary informationAbility to keep calm under pressure

Preferred Qualifications

Advanced degree (e.g., Masters, PhD, etc,)Experience with managing IT systems or providing business operational supportExperience using document management, submission publishing, registration management, labeling and/or change control systemsBasic understanding of information taxonomies, master data management or other structured data conceptsBasic understanding of data warehousing, data lakes and reporting/analytics platforms or conceptsProficiency in other language(s) most common/useful are Dutch, Japanese, Spanish, Portuguese, French, Russian, ChineseWorking EnvironmentChoose one of the first two statements below to describe onsite work expectations for the role. Additional points may include travel requirements, office or laboratory working environment, highly collaborative environment, description of equipment used, etc.At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance withCategoryAstellas is committed to equality of opportunity in all aspects of employment.EOE including Disability/Protected Veterans