Research Associate I

Responsibilities

• Define, organize, and execute activities related to product design changes and new product registrations in compliance with international regulations.
• Provide technical assessments for product changes involving design, labeling, raw materials, and manufacturing support.
• Lead and coordinate technical activities with global stakeholders to ensure project commitment and quality.
• Prepare technical reports and formulate responses to regulatory authority inquiries based on internal and external data.
• Establish and maintain technical and design documentation following Good Documentation Practices.
• Participate in multi-functional international project teams to drive effective collaboration and deliverables.
• Conduct exploration of innovation concepts and technology platforms using a critical, "out-of-the-box" mindset.

Requirements

• Master's degree in Chemistry, Pharmacy, or a related discipline with at least 4 years of relevant experience, OR a PhD in Chemistry or Pharmacy with relevant experience.
• Proven experience in pharmaceutical product development and life cycle management, specifically with sterile injectable or parenteral formulations.
• Demonstrated track record of leading small-scale projects, particularly Change Controls within the pharmaceutical industry.
• Proficiency in Statistics and Six Sigma tools.
• Strong ability to work in a matrix environment and manage stakeholders both locally and globally.
• Fluency in English with excellent written and oral communication skills.

Preferred Qualifications

• Hands-on knowledge of Design Control documentation and processes.
• Familiarity with international, regional, and national regulatory standards.
• Experience with project management, including budget and timeline accountability.

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 advanced digital solutions and transformative therapies.