General Information

Job Advert Title
Manager, Regulatory Operations
Function/Business Area
Regulatory Affairs
Department
Publishing and Submissions
Employment Class
Permanent

Description

Regulatory Operations Manager


About Astellas:


At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others.

Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It’s a culture of doing good for others and contributing to a sustainable society. Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners. Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity.

We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership. Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.


About this job:


  • Designs and tests reports sharing Regulatory information with cross-functional stakeholders including Pharmacovigilance, Medical Affairs, Development Operations, Finance and senior and top management
  • Performs or oversees one or more aspects of the daily operation of the global Regulatory Information Management system including reporting, data entry, quality control and metrics
  • Identifies opportunities to align vocabulary management across RA systems
  • Contributes and collaborates with RA stakeholders in order to provide regulatory information to other systems or outside of RA according to system integration logic
  • Supports communication and collaboration with RA stakeholders in order to capture correct regulatory events’ information completely in a timely manner
  • Supports to provide overviews/reports to stakeholders and raise awareness of missing information or possibility of missing information
  • 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 Regulatory Affairs, 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
  • Represents Regulatory Operations on various project teams / task forces as a subject matter expert in the field of electronic document management, submissions management and dossier publishing
  • Represents the Astellas Publishing & Submission function in meetings with regulatory authorities, usually in conjunction with other RA staff

Experience and Knowledge:


  • At least three years’ experience in the pharma industry with some experience in a regulatory operations role
  • Demonstrated accomplishments and/or education will be evaluated and substituted for extent of experience, as needed
  • Ability to work independently with minimal direction and within project teams, committees, etc. to attain group goal
  • Proven ability to prioritize and multi-task with minimal supervision based on interactions with project team members
  • If managing staff the incumbent should have experience managing people and/or teams or otherwise demonstrate the ability to do so
  • Strong ability to communicate effectively in writing and verbally in English
  • Ability to multi-task across multiple projects and deliverables
  • High integrity to maintain confidential and proprietary information
  • Ability to keep calm under pressure

Education/Qualifications:


  • Advanced degree (e.g., Masters, PhD, etc,)
  • Proficiency in other language(s) – most common/useful are Dutch, Japanese, Spanish, Portuguese, French, Russian, Chinese

Additional information:


  • Full time - Permanent Role
  • Role based in Netherlands

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.