RA Manager

Responsibilities

• Lead India BRD Drug RA compliance and regulatory execution for R&D activities.
• Act as the primary liaison with CDSCO and State FDA for obtaining and maintaining statutory licenses, registrations, and permits.
• Manage regulatory submissions, including import licenses, technical files, and dossiers.
• Lead inspection readiness programs, host regulatory audits, and manage deficiency responses and closures.
• Monitor and implement evolving regulatory requirements and policy updates impacting R&D operations.
• Provide subject matter expertise on import regulations, sample logistics, and R&D material movement.
• Collaborate with global regulatory teams, R&D, and manufacturing to mitigate compliance risks.
• Develop and disseminate regulatory knowledge through training and mentoring to the R&D organization.

Requirements

• Minimum 5+ years of Regulatory Affairs experience specifically within India.
• Direct hands-on experience with CDSCO interactions and submissions.
• Proven track record with State FDA operations and licensing.
• Experience managing regulatory audits, inspections, and closure processes.
• Bachelor's or Master's degree in Pharmaceutical Sciences, Life Sciences, Chemistry, or a related scientific discipline.
• Strong regulatory writing skills and high attention to detail.

Preferred Qualifications

• Experience in Pharma R&D environments, specifically supporting lab-based compliance (formulation, analytical, or sterility assurance).
• Demonstrated expertise in GLP/GMP or regulatory intelligence.
• Experience managing complex stakeholders across both local and global teams.

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. For 70 years, our team has driven meaningful innovations in kidney care, and we are now expanding our commitment to transforming vital organ therapies through digital solutions and advanced services.