Manager, Planning & Administration

About Astellas Pharma

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong to Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.

Astellas’ Global Capability Centres – Overview

Astellas’ Global Capability Centres (GCCs) are strategically located sites that give Astellas the ability to access talent across various functions in the value chain and to co-locate core capabilities that are currently dispersed. Our three GCCs are located in India, Poland and Mexico.

The GCCs will enhance our operational efficiency, resilience and innovation potential, enabling a timely response to changing business demands.

Our GCCs are an integral part of Astellas, guided by our shared values and behaviors, and are critical enablers of the company’s strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients.

Purpose and Scope of the Manager, Planning & Administration Role

The Manager, Planning & Administration collaborates with global stakeholders to execute major P&A programs/workstreams and continuous improvement. This role contributes to the RAPV Portfolio/PMO to maintain oversight of the non-drug project portfolio and serves as Project Manager for selected non-drug initiatives, while running operations for Training Management (LMS including GVP) and Records Information Management (RIM) to ensure regional/global alignment and service quality.

Responsibilities And Accountabilities

• Contributes to RAPV Portfolio/PMO to maintain oversight of the non-drug project portfolio; serves as Project Manager for selected initiatives; supports process improvement and organizational transformation with internal/external stakeholders.
• Contributes to the design, implementation, and ongoing monitoring of key business processes in RAPV (annual, mid- and long-term business goals, budget, and resource planning).
• Operates budget/forecast cycles; prepares analyses and scenarios; supports resource tracking with CRDO.
• Implements and maintains Training Management (LMS including GVP); monitors compliance and executes remediation plans.
• Maintains RIM procedures and controls; supports audits/inspections and corrective actions.
• Coordinates cross-functional stakeholders across regions; ensures alignment and timely delivery.
• Supports maintenance of the Business Continuity Plan (BCP) and contributes to response activities when BCP is activated.

Required Qualifications

• Bachelor’s degree (science or technology is preferred).
• At least seven years’ experience in a regulatory operations role or similar position associated with regulated processes and content in the pharma industry.
• Demonstrated accomplishments and/or education will be evaluated and substituted for extent of experience, as needed.
• Proven ability to coordinate priorities and tasks across project teams, committees, etc. to attain group objectives.
• Proven ability to anticipate and proactively resolve project or procedural issues.
• Demonstrated experience championing new processes and leading change management activities.
• 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

• Bachelor’s degree or equivalent (pharmacy, science, technology preferred).
• 7+ years in the pharmaceutical industry.
• 3+ years of program/project leadership with demonstrated experience in portfolio/PMO operations and project management for non-drug projects.
• Strong English communication; proven ability to coordinate across regions/time zones and manage multiple deliverables.
• High integrity to manage confidential and proprietary information.
• Experience with Training Management (Learning Management System, including Good Pharmacovigilance Practices).
• Experience with Records Information Management (RIM) operations.
• Project management training/certification (e.g., PMBOK, PRINCE2); experience with portfolio/project management tools and dashboards.
• RA/PV operations experience.
• Additional language skills depending on posting region.

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.

Key skills/competency

• Planning
• Administration
• Project Management
• Portfolio Management
• Regulatory Operations
• Training Management (LMS/GVP)
• Records Information Management (RIM)
• Process Improvement
• Stakeholder Coordination
• Budget Management