Research Associate III

Responsibilities

• Provide technical leadership and subject-matter expertise across product lifecycle management activities.
• Independently own and execute product design changes and new product registrations in compliance with international regulatory requirements.
• Lead technical assessments for changes related to formulation, design, labeling, raw materials, and manufacturing support.
• Coordinate cross-functional technical activities with global stakeholders in R&D, Regulatory Affairs, Quality, and Supply Chain.
• Prepare high-quality technical responses and reports to address regulatory authority queries.
• Maintain and update design and technical documentation in accordance with Good Documentation Practices.
• Mentor and coach junior team members to strengthen technical depth and report-writing excellence.

Requirements

• Master's degree in Chemistry, Pharmacy, or a related scientific discipline.
• Minimum 10 years of relevant R&D experience in pharmaceutical or medical products.
• Proven experience leading change controls and moderate-scale projects in a regulated environment.
• Hands-on experience with design control processes and documentation.
• Working knowledge of global regulatory frameworks and standards.
• Proficiency in Microsoft Office, Teams, and WebEx.
• Strong written, verbal, and presentation skills for engaging global stakeholders.

About the Company

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. Built on a 70-year legacy of innovation in kidney care, we are dedicated to elevating the dialysis experience through digital solutions and advanced services while investing in the future of vital organ therapies.