Regulatory Affairs Vendor Oversight & Relationship Partner
Job ID: 25-PJT00256-01M
Location: Bengaluru, India
Employment Type: Full-Time
Work Mode: Hybrid (On-site presence required)
Experience Required: 7–12 Years
Function: Regulatory Affairs | Vendor Oversight | Governance
Industry: Pharmaceuticals | Life Sciences | Biotechnology
Job Overview
Astellas is seeking a highly experienced Regulatory Affairs Vendor Oversight & Relationship Partner to support and govern outsourced Regulatory Affairs (RA) activities, with additional oversight of Pharmacovigilance (PV) vendors as required. This role is a key contributor within Astellas’ Global Capability Centers (GCCs) and plays a critical role in ensuring compliant, efficient, and value-driven vendor partnerships across global R&D operations.
The position is based in Bengaluru, India, and requires close collaboration with internal stakeholders, vendor managers, subject matter experts (SMEs), Quality, and Procurement teams.
About Astellas – Global Capability Centers
Astellas’ Global Capability Centers (GCCs) in India, Poland, and Mexico enable access to global talent and centralized expertise across the pharmaceutical value chain. These centers strengthen operational resilience, innovation, and scalability while supporting Astellas’ mission to transform innovative science into value for patients worldwide. GCCs operate as an integral part of Astellas, guided by shared values, ethics, and compliance-driven execution.
Purpose and Scope
This role is responsible for end-to-end oversight and governance of outsourced Regulatory Affairs activities, ensuring vendors deliver high-quality outcomes in compliance with contractual, corporate, and regulatory requirements. The role also supports Pharmacovigilance vendor oversight as business needs require.
Key Responsibilities
Vendor Oversight & Governance
Oversee execution of outsourced RA and PV activities in line with governance frameworks, relationship manuals, and escalation procedures
Ensure vendor compliance with agreed KPIs, SLAs, contracts, SOPs, and regulatory requirements
Monitor vendor performance and drive continuous improvement in efficiency, quality, and productivity
Lead or participate in vendor governance and relationship management meetings
Business Continuity & Risk Management
Ensure vendor business continuity and backup plans are established, tested, and maintained
Confirm critical RA/PV processes are covered in Functional Business Continuity Plans (BCPs)
Identify, assess, and escalate operational risks or disruptions impacting business-critical activities
Process Improvement & Transformation
Identify and manage change initiatives to enhance vendor-delivered processes
Contribute to RA/PV technology and transformation initiatives, including vendor-impacting system enhancements
Vendor Selection, Transition & Contract Management
Support vendor selection, onboarding, and transitions aligned with RA and R&D outsourcing strategies
Collaborate with Procurement, Global Contract Office (GCO), vendor managers, and SMEs to ensure accurate and timely contracting
Support contract compliance and vendor relationship documentation
Financial & Performance Management
Support vendor financial planning, budget forecasting, workload and case volume projections
Review and support approval of vendor invoices, where applicable
Quality & Compliance
Partner with Quality Assurance and vendor managers to coordinate vendor audits and inspections
Represent Astellas during Health Authority inspections involving outsourced vendors
Ensure deviations, SCARs, and CAPAs are documented in eQMS and closed within defined timelines
Escalate compliance issues through formal governance channels
Training & Capability Development
Ensure vendor staff complete required training and documentation in collaboration with Learning and Development teams
Coordinate PV awareness and role-specific training with vendor managers and SMEs
Maintain oversight of vendor training compliance and records
Required Qualifications
Bachelor’s degree (BA/BS) in a scientific, healthcare, or related discipline
Minimum 7 years of relevant industry experience in vendor oversight, governance, or outsourcing within Regulatory Affairs, Pharmacovigilance, Clinical Development, or R&D operations
Proven experience in vendor contract writing, negotiation, and management
Strong working knowledge of Regulatory Affairs, Pharmacovigilance, and data privacy regulations and guidelines
Excellent written and verbal communication skills in English
Strong interpersonal and stakeholder management skills with cross-cultural awareness
Demonstrated ability to think strategically and resolve complex, global operational challenges
Proven leadership skills with the ability to influence internal and external stakeholders
Strong analytical, problem-solving, and decision-making capabilities
Ability to work independently, manage priorities, and deliver results with minimal supervision
Experience in process improvement, sourcing, cost analysis, budgeting, invoicing, and financial oversight
Preferred Qualifications
Project Management experience or certification
Advanced proficiency in MS Word and Excel, including costing and financial models
In-depth understanding of contract compliance and regulatory requirements specific to RA and PV outsourcing
Location
Bengaluru, India
Important Notice
Astellas does not charge fees for recruitment. All official communication will originate from a verified Astellas email address or an authentic Astellas LinkedIn profile. Candidates are advised to report any suspicious activity via LinkedIn Help.
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