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 new users and 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
• Creates job aides 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 dssier publishing

• May 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 five 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

Preferred Qualifications:

• Advanced degree (e.g., Masters, PhD, etc,)
• At least six years’ experience in a regulatory operations role or similar
• Experience with managing IT systems or providing business operational support
• Experience using document management, submission publishing, registration management, labeling and/or change control systems
• Basic understanding of information taxonomies, master data management or other structured data concepts
• Basic understanding of data warehousing, data lakes and reporting/analytics platforms or concepts
• Proficiency in other language(s) – most common/useful are Dutch, Japanese, Spanish, Portuguese, French, Russian, Chinese

Working Environment

• 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 with Astellas’ Responsible Flexibility Guidelines.

What awaits you at Astellas?

• Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
• Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
• Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
• A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

Our Organizational Values and Behaviors

Values: Innovation, Integrity and Impact sit at the heart of what we do.

Behaviors: We come together as ‘One Astellas’, working with courage and a sense of urgency. We are outcome focused and consistently take accountability for our personal contribution.