Associate, RAPV Business Operations

Business Associate Role

The Business Associate supports the Regulatory Affairs & Pharmacovigilance (RAPV) operations function by executing and coordinating supplier/consultant onboarding and offboarding, and managing purchase order (PO) activities.

The role ensures timely access provisioning, compliant vendor setup, accurate PO creation and approvals, and diligent documentation aligned with GxP and financial controls.

The position also supports the business unit with Microsoft SharePoint and Teams setup, meeting arrangements, Outlook mailbox administration, and monthly reporting and metrics collection.

Responsibilities and Accountabilities:

Onboarding and Offboarding (RAPV vendors, consultants, and tools):

• Coordinate new hire setup by managing the logistics of setting up new employees, including equipment, network/virtual desktop, system(s) access, and workspace.
• Handle all necessary paperwork and ensure compliance with legal requirements.
• Create and update handbooks, checklists, and other materials to support onboarding/offboarding process.
• Set up and maintain accurate vendor master data (legal entity, remit-to, tax settings, payment terms) and RAPV-specific attributes (GxP impact, risk tier, contract link, approved scopes) in ERP/procurement systems.
• Coordinate role-based access provisioning to RAPV systems (RIM/EDMS/eCTD publishing tools, translation portals & others), ensuring training completion, user attestations, and segregation of duties aligned with Quality and IT controls.
• Provide onboarding guidance to internal stakeholders.
• Manage offboarding by terminating system access promptly, collect deliverables, ensure final filing in EDMS/RIM, reconcile and close POs, confirm data return/deletion per DPA, update approved supplier lists, and retain audit-ready records.
• Continuously analyze and improve onboarding and offboarding procedures based on feedback and best practices.

Purchase Order Management:

• Create, process and manage POs for RA-PV services and fees (e.g., publishing, translations, regulatory strategy/CMC consultants, health authority fees, regulatory intelligence subscriptions, inspections, safety activities, labelling artwork services, software licenses) across multiple Astellas locations.
• Ensure accurate lines (items, units, quantities, pricing), appropriate delivery/payment terms, and linkage to MSAs/SOWs or fee schedules; enforce preferred supplier usage.
• Set up and maintain accurate vendor master data (legal entity, remit-to, tax settings, payment terms) and RAPV-specific attributes (GxP impact, risk tier, contract link, approved scopes) in ERP/procurement systems in collaboration with appropriate Finance and other internal resources.
• Route POs through approval workflows; expedite approvals and resolve exceptions.
• Obtain order acknowledgments and track fulfillment; coordinate changes, extensions, or cancellations with requesters and vendors.
• Monitor open POs and aging; maintain visibility for time-sensitive expenditures (e.g., agency fee payments tied to filings) and close out completed orders.
• Support tracking of invoicing and spend management against internal budgets in collaboration with other internal stakeholders.
• Ensure all purchasing activities comply with company policies and procedures.

KPI & Metric Reporting:

• Coordinate the collection and assembly of functional area KPI & Metrics with other internal stakeholders
• Support distribution of information to stakeholders outside of functional area

Stakeholder Support and Communication:

• Serve as a central point of contact for relevant stakeholders on onboarding, offboarding, and PO status; provide clear timelines, next steps, and guidance.
• Collaborate with Regulatory Affairs & Pharmacovigilance (RAPV) teams, Quality/QA, Legal/Privacy, HR, IT, Procurement, Finance/AP, and business requesters to resolve issues quickly.