Research Associate III (PDO)
Location: Bengaluru, India
Job ID: JR-179675
Category: Research and Development
Date Posted: July 22, 2025
Company: Vantive
Job Summary:
Vantive is seeking a Research Associate III (PDO) to support the Kidney Care Drug Products Organization. This role is focused on leading technical solutions for new product development and lifecycle management, particularly around parenteral formulations and drug-device combination products. You will play a key role in mentoring team members, managing product design documentation, supporting global regulatory submissions, and driving quality and compliance.
Key Responsibilities:
Serve as Solution Lead and technical subject matter expert for R&D kidney care projects.
Lead and support new product development and lifecycle activities following global quality and environmental regulations.
Mentor junior scientists and guide technical execution to align with milestones and project goals.
Review and approve Design Control documentation in line with internal procedures and industry standards.
Maintain and update technical specifications, including product characteristics and associated verification/validation documents.
Oversee and execute product/supplier/labeling changes related to lifecycle management.
Support product risk assessment by contributing design-related insights for risk management documentation.
Assist in global product registration and regulatory submissions by providing technical support.
Provide resource estimation and planning input to project managers.
Ensure effective global collaboration and communication across cross-functional teams.
Required Qualifications:
Master’s in Chemistry or M. Pharm. with 10–12 years of relevant experience
–OR– Ph.D. in Pharmaceutical or related sciences with 7–10 years of relevant experience
Strong expertise in parenteral formulation development
Experience with drug-device combinations and lifecycle management
Deep knowledge of Design Control, stability studies, clinical development, registration, and process transfer
Solid understanding of product risk management principles for medical devices and pharmaceuticals
Familiarity with international regulatory standards and submission requirements
Proven leadership in project/program management within the pharmaceutical domain
Strong English communication skills (written and verbal)
Ability to lead strategy execution and independently manage projects
Desirable Skills:
Stakeholder engagement and global team collaboration
Ability to translate upper management vision into action plans
Comfortable working independently and managing multiple priorities
Accessibility Commitment:
Vantive provides reasonable accommodations for applicants and employees with disabilities. You may click here to submit an accommodation request with your contact information and details.
Recruitment Fraud Notice:
Beware of employment scams. Vantive does not request financial or personal data outside of official channels. Learn more by reviewing our official Recruitment Fraud Notice on our careers page.
Estimated Salary: ₹18–28 LPA (based on senior-level pharma R&D roles in India involving drug-device product development)
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