Associate, RAPV Business Operations
Location: Bengaluru
Job ID: 1963
Department: Regulatory Affairs and Pharmacovigilance (RAPV)
Employment Type: Full-Time
Experience Required: 2–4+ years in operations support, procurement, vendor onboarding, or related roles
Company: Astellas Pharma
Job Overview
The Associate, RAPV Business Operations supports Regulatory Affairs and Pharmacovigilance (RAPV) operations by managing vendor onboarding and offboarding processes, purchase order administration, and operational coordination activities. This role ensures compliant supplier setup, accurate financial processing, access provisioning, and documentation aligned with GxP standards and financial control requirements.
The position also provides operational support through collaboration with cross-functional teams, administration of digital collaboration tools, and management of reporting and performance metrics. This opportunity is ideal for professionals seeking to build expertise in regulatory operations, pharmacovigilance support functions, and business process management within the life sciences industry.
Key Responsibilities
Onboarding and Offboarding Management
Coordinate onboarding logistics for vendors, consultants, and employees, including system access, equipment setup, and workspace arrangements.
Ensure compliance with legal, regulatory, and company policies during onboarding and offboarding processes.
Maintain and update onboarding materials, checklists, and process documentation.
Manage vendor master data including legal entity details, tax settings, payment terms, and RAPV-specific attributes such as GxP impact and risk classification.
Coordinate role-based system access provisioning, ensuring compliance with quality and IT security standards.
Execute offboarding activities including access termination, deliverable collection, documentation filing, purchase order closure, and audit-ready record retention.
Continuously evaluate and improve onboarding and offboarding procedures to enhance efficiency and compliance.
Purchase Order and Vendor Management
Create and manage purchase orders for regulatory and pharmacovigilance services, including publishing, translation, regulatory consulting, health authority fees, safety activities, and software licensing.
Ensure purchase orders are accurately structured with correct pricing, quantities, and contract linkage.
Route purchase orders through approval workflows, resolve exceptions, and monitor order fulfillment.
Maintain vendor data in procurement systems in collaboration with finance and internal stakeholders.
Track purchase order status, monitor aging transactions, and ensure timely closure of completed orders.
Support invoice tracking, budget monitoring, and spend management activities.
Ensure purchasing activities comply with internal policies and financial procedures.
KPI and Metrics Reporting
Support the collection, compilation, and reporting of functional KPIs and operational metrics.
Assist in distributing performance insights to internal and external stakeholders.
Stakeholder Coordination and Communication
Serve as a central point of contact for onboarding, offboarding, and purchase order status updates.
Collaborate with Regulatory Affairs, Pharmacovigilance, Quality Assurance, Legal, HR, IT, Procurement, and Finance teams to resolve operational issues.
Provide clear communication, timelines, and process guidance to stakeholders.
Operational Systems Support
Provide support for Microsoft SharePoint, Teams, Outlook administration, and meeting coordination.
Assist in documentation management and reporting activities for operational processes.
Educational Qualifications
Associate’s or Bachelor’s degree in Business Administration, Life Sciences, Supply Chain, Finance, or related field.
Equivalent professional experience may be considered.
Experience Requirements
2–4+ years of experience in operations support, procurement, accounts payable, vendor management, or shared services within life sciences, pharmaceutical, biotechnology, medical device, or regulated industries.
Required Skills and Competencies
Strong attention to detail and documentation management skills with the ability to maintain audit trails.
Experience working with collaboration tools such as Microsoft SharePoint, Office, Teams, and OneDrive.
Excellent written and verbal communication skills in English.
Strong stakeholder management and cross-functional coordination abilities.
Analytical problem-solving skills with the ability to resolve discrepancies and manage deadlines.
Understanding of process controls, compliance requirements, and continuous improvement practices.
High level of integrity in handling sensitive regulatory and financial data.
Preferred Qualifications
Experience supporting IT systems or business operations functions.
Familiarity with ERP or procurement platforms such as SAP, NetSuite, Coupa, Ariba, or Workday.
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