Regulatory Affairs Manager – India R&D

About the role

The Regulatory Affairs (RA) Manager will lead compliance and regulatory execution for Vantive's India R&D site, overseeing laboratories and external testing partners. This role ensures that all research activities meet local and global regulatory standards, supporting the company’s mission to improve kidney care and vital organ therapies.

Key responsibilities

• Ensure full regulatory compliance for all R&D activities, monitoring evolving requirements and implementing corrective actions.
• Maintain deep knowledge of Indian regulations (CDSCO, State FDA, CBN, DSIR) and relevant global expectations, providing guidance on import, testing, and export.
• Act as primary liaison with central and state authorities to obtain, renew, and maintain licenses, registrations, and permits for the site and third‑party labs.
• Lead audit and inspection readiness, manage audit observations, and coordinate closure activities.
• Prepare, review, and submit India registrations, import licenses, technical files, and dossiers, and manage regulatory portal submissions (SUGAM, ONDLS, NSWS).
• Develop and deliver regulatory training to the R&D organization, mentoring team members on writing and compliance.
• Collaborate with global regulatory teams, manufacturing, and external labs, serving as escalation point for regulatory risks.

Required profile

• Minimum 5 + years of Regulatory Affairs experience in India, with hands‑on CDSCO interactions and State FDA licensing.
• Experience in pharma R&D environments, preferably supporting lab‑based compliance (formulation, analytical, sterility assurance).
• Strong regulatory writing and documentation skills, attention to detail, and a compliance mindset.
• Bachelor’s or Master’s degree in Pharmaceutical Sciences, Life Sciences, Chemistry, Engineering or related field.
• Additional certifications in GLP/GMP or regulatory intelligence are advantageous.

Required skills

• Regulatory writing
• GLP/GMP compliance knowledge
• Regulatory intelligence and monitoring