RA Manager

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. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Job Title:

India RA Manager, R&D  

Job Profile:

Manager– Quality & Regulatory– General Quality and Regulatory

Group - Family:

Quality– General Quality and Regulatory

Date:

May 2026

Grade:

18

Summary:

This section focuses on the main purpose of the job in one to four sentences.

Manages and leads India BRD Drug RA compliance and regulatory execution, including laboratories and external testing partners

Essential Duties and Responsibilities:

Regulatory Compliance Leadership:

-Ensure full regulatory compliance for R&D activities performed at the site.

-Monitor, interpret, and implement evolving regulatory requirements and policy updates impacting R&D operations.

-Assess potential business impact arising from regulatory non-compliance. Advise mitigations, and drive implementation of corrective/preventive actions to ensure sustained compliance.

Regulatory Intelligence:

-Maintain deep knowledge of India local requirements (e.g., CDSCO, State FDA, CBN, DSIR) and relevant global regulatory expectations (e.g. pharmacopoeial requirements such as EU/US Pharmacopeia expectations where applicable).

-Provide subject matter guidance on import regulations and compliance requirements relevant to Drug Products and Sciences, including R&D material movement and sample logistics.

-Demonstrate in-depth expertise in relevant acts/rules governing import, testing, and export-related needs (as applicable to the site scope).

Licenses, Registrations, and Permits:

-Act as the primary liaison with Central Government authorities (CDSCO) and State Regulatory Bodies (State FDA) for obtaining, renewing, and maintaining statutory licenses, registrations, and permits.

-Obtain and maintain regulatory licenses/approvals for R&D site operations, internal labs, and applicable third-party testing facilities.

-Support and/or lead regulatory compliance for specialized laboratory areas such as formulation labs, container testing labs, sterility assurance, and other R&D science capabilities within the site scope.

-Lead or support activities related to obtaining and maintaining DSIR certification for the R&D Center, including documentation and regulatory coordination.

Agency Interface, Audits, and Inspection Readiness :

-Directly interface with regulatory agencies and lead audit/inspection engagements, including driving audit preparation, hosting, and closure activities.

-Lead inspection readiness programs for the site, including documentation readiness, staff preparedness, and response management.

-Manage audit observations, deficiency responses, commitments, and closure documentation within required timelines.

Regulatory Submission Management:

-Lead preparation, review, and submission of India registrations, import licenses, technical files, and dossiers, as applicable to R&D and site regulatory needs.

-Act as the primary interface for regulatory correspondence with CDSCO and relevant bodies; ensure accurate, timely, and compliant communications.

-Coordinate and manage regulatory portal submissions and tracking (e.g., SUGAM, ONDLS, NSWS and related systems as applicable).

Training and Development:

-Develop and disseminate regulatory knowledge to the R&D organization through training, coaching, and practical guidance.

-Provide hands-on support and mentoring to team members, ensuring strong regulatory writing, compliance execution, and audit readiness capabilities.

Cross-Functional and Global Stakeholder Collaboration

-Act as an interface with global regulatory teams, R&D, manufacturing, and third-party labs; serve as an escalation point for regulatory risks and compliance issues.

-Provide clear regulatory guidance to project teams and leadership, enabling compliant decision-making and execution.

Qualifications:

-Minimum 5+ years of Regulatory Affairs (India) experience with direct hands-on exposure to:

·       CDSCO interactions and submissions

·       State FDA operations and licensing

·       Regulatory audits/inspections and closure management

-Pharma R&D experience is strongly preferred, with capability to support lab-based compliance environments (formulation/analytical/testing/sterility assurance scope as applicable).

-Excellent regulatory writing and documentation skills with strong attention to detail and compliance mindset.

-Strong coordination skills and ability to manage complex stakeholders across global and local teams.

Education and/or Experience:

-Bachelor’s or Master’s degree in Pharmaceutical Sciences, Life Sciences, Chemistry, Engineering, Sciences, or a related discipline (depending on domain).

-Additional certifications or demonstrated expertise in GLP/GMP, regulatory compliance, or regulatory intelligence are advantageous.

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

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