Regulatory Affairs Vendor Oversight & Relationship Partner
Company: Astellas Pharma Inc.
Location: Bengaluru, India (Hybrid – on-site work required)
Experience Required: 7+ years in Regulatory Affairs (RA), Pharmacovigilance (PV), or Clinical Development with vendor management exposure
Job Type: Full-Time
About Astellas Global Capability Centers (GCCs)
Astellas’ GCCs in India, Poland, and Mexico centralize core capabilities across the pharmaceutical value chain. These centers enhance operational efficiency, resilience, and innovation, enabling timely responses to changing business demands. They are critical enablers of Astellas’ strategic priorities and commitment to transforming innovative science into value for patients.
Role Purpose
The Regulatory Affairs Vendor Oversight & Relationship Partner will:
Lead oversight of RA and PV vendors, ensuring high-quality, compliant, and timely delivery of outsourced activities
Establish and maintain effective, collaborative relationships with vendor managers, points of contact, and internal subject matter experts (SMEs)
Ensure compliance with contracts, corporate policies, and regulatory requirements, implementing corrective actions where necessary
Support vendor selection, onboarding, transitions, contracts, and financial management
Key Responsibilities
Vendor Oversight & Governance
Monitor vendor performance against KPIs/SLAs and contractual obligations
Ensure adherence to governance procedures, relationship manuals, and escalation mechanisms
Drive process efficiency and productivity improvements with vendors
Lead or participate in vendor governance meetings
Business Continuity & Risk Management
Confirm business continuity and backup plans for critical vendor processes
Escalate risks or operational disruptions promptly
Process Improvement & Transformation
Identify and lead change initiatives to improve vendor-delivered processes
Support RA/PV technology enhancement and transformation projects
Vendor Selection, Transition & Contracts
Assist in vendor selection, onboarding, and contract management
Collaborate with Procurement, Global Contract Office (GCO), and functional SMEs for accurate and timely contracting
Financial & Performance Management
Support vendor-related budgeting, workload analysis, and financial forecasting
Review and approve vendor invoices as required
Quality & Compliance
Partner with QA to coordinate vendor audits and inspections
Represent the client during Health Authority inspections
Ensure deviations and SCARs are tracked and closed in eQMS
Escalate non-compliance impacting critical business functions
Training & Capability Development
Coordinate and track vendor training compliance
Collaborate on PV awareness and role-specific training programs
Maintain oversight of training documentation and compliance
Required Qualifications
Bachelor’s degree (BA/BS)
7+ years supporting vendor management in RA, PV, or Clinical Development
Experience with vendor contracts, invoicing, and compliance management
Strong communication, negotiation, and interpersonal skills
Proven ability to lead, influence, and build consensus across global stakeholders
Experience in process improvement, cost analysis, and project management
Independent worker with strong analytical and decision-making skills
Knowledge of RA, PV, and data privacy regulations
Preferred Qualifications
Advanced MS Word and Excel skills for costing models
Understanding of regulatory compliance specific to RA and PV
Experience managing global vendor partnerships
Application & Equal Opportunity
Astellas is committed to equal employment opportunities, including disability and protected veterans.
Beware of recruitment scams – official communication will only come from verified Astellas LinkedIn profiles or company emails.
Apply Now
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