Associate – Regulatory Affairs & Pharmacovigilance (RAPV) Business Operations | Bengaluru, India
Location: Bengaluru, India
Department: Regulatory Affairs & Pharmacovigilance (RAPV)
Employment Type: Full-Time
ThePharmaDaily.com is featuring an opportunity for an Associate – RAPV Business Operations in Bengaluru, India. This role is ideal for professionals with experience in procurement operations, vendor lifecycle management, regulatory business support, and GxP-compliant environments within the pharmaceutical, biotech, or medical device industries.
This position supports Regulatory Affairs (RA) and Pharmacovigilance (PV) operational excellence by managing supplier onboarding/offboarding, purchase order (PO) governance, access provisioning, and compliance-aligned documentation processes.
Role Overview
The Associate, RAPV Business Operations, plays a critical role in supporting regulatory and pharmacovigilance functions through structured operational coordination. The position ensures compliant vendor setup, timely system access provisioning, accurate purchase order management, financial control alignment, and audit-ready documentation under GxP standards.
The role also supports business operations through SharePoint and Microsoft Teams administration, reporting, mailbox management, and KPI tracking to maintain process transparency and efficiency.
Key Responsibilities
Vendor Onboarding & Offboarding (RAPV Vendors, Consultants, Tools)
Coordinate end-to-end onboarding for new consultants and vendors, including equipment setup, system access, and workspace provisioning.
Maintain compliant vendor master data including legal entity information, tax settings, payment terms, GxP classification, risk tiering, and contract linkage in ERP/procurement systems.
Manage role-based access provisioning to RAPV systems such as RIM, EDMS, eCTD publishing tools, and translation portals.
Ensure training completion, user attestations, and segregation of duties aligned with Quality and IT security standards.
Develop and update onboarding/offboarding documentation including checklists and process guides.
Oversee compliant offboarding activities including system access termination, PO reconciliation, EDMS/RIM final filing, DPA data confirmation, and audit-ready record retention.
Continuously improve onboarding/offboarding workflows based on feedback and best practices.
Purchase Order (PO) Management – Regulatory & PV Services
Create, process, and manage POs for regulatory and pharmacovigilance services including publishing, translations, CMC consulting, regulatory intelligence subscriptions, inspection support, safety activities, labeling artwork, and software licensing.
Ensure accuracy of pricing, quantities, units, payment terms, and alignment with MSAs/SOWs.
Route POs through approval workflows and resolve exceptions to prevent delays in regulatory timelines.
Monitor open POs, track aging reports, and support timely closure of completed orders.
Coordinate with Finance and Accounts Payable to support invoice tracking and budget alignment.
Ensure procurement activities adhere to corporate financial controls and compliance standards.
KPI & Reporting Support
Collect and consolidate RAPV functional metrics and KPIs.
Support reporting and distribution of operational dashboards to stakeholders.
Stakeholder Collaboration
Serve as primary contact for onboarding, offboarding, and PO-related queries.
Collaborate with Regulatory Affairs, Pharmacovigilance, Quality/QA, Legal, HR, IT, Procurement, and Finance to ensure timely issue resolution.
Provide clear communication on timelines, compliance requirements, and process updates.
Experience Required
Minimum 2–4+ years of experience in operations support, procurement, vendor onboarding, accounts payable, or shared services within life sciences (pharma, biotech, medical devices) or a similarly regulated industry.
Hands-on experience supporting GxP-controlled processes and audit documentation preferred.
Experience managing vendor lifecycle processes and ERP/procurement systems required.
Exposure to regulatory or pharmacovigilance environments is highly advantageous.
Educational Qualifications
Associate’s or Bachelor’s degree in Business Administration, Life Sciences, Supply Chain, Finance, or related field (or equivalent professional experience).
Technical Skills
Proficiency in Microsoft Office Suite including SharePoint, Teams, OneDrive, and Outlook.
Experience with ERP and procurement platforms such as SAP, NetSuite, Coupa, Ariba, or Workday preferred.
Strong documentation and audit trail management skills.
Core Competencies
High attention to detail and strong compliance mindset
Knowledge of GxP principles and financial governance controls
Analytical problem-solving and risk identification skills
Cross-functional stakeholder coordination
Process improvement orientation
Strong written and verbal communication skills in English
Integrity and discretion in handling sensitive regulatory and financial information
Why This Role is Strategically Important
Direct exposure to global regulatory operations and pharmacovigilance business support
Opportunity to work within highly regulated pharmaceutical environments
Involvement in regulatory submission support, compliance governance, and financial controls
Career progression pathway into Regulatory Operations, PV Operations, or Global Clinical Business Operations
Professionals seeking to build or advance careers in regulatory operations, pharmacovigilance support, procurement governance, and GxP-compliant business operations are encouraged to apply.
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