Sr Manager, QARA India

Vantive

Gurugram District

On-site

INR 4,000,000 - 8,000,000

Full time

2 days ago

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Job summary

Vantive, a vital organ therapy company, seeks an India RAQA Senior Manager to lead day-to-day QA and regulatory affairs operations, including R&D regulatory support, to ensure compliance with applicable regulatory requirements and quality standards.

The role drives the development and continuous improvement of QMS, regulatory strategies, and product lifecycle compliance, while partnering with R&D, CDCSO, and cross-functional teams to enable development, registration, and commercialization.

Qualifications

Minimum 12+ years of RA/QA experience in healthcare/pharma.
Strong knowledge of Indian regulatory requirements (CDCSO, Drugs Act, GMP).
Proven experience in regulatory submissions, inspections, compliance.
Minimum 5 years of people management in cross-functional settings.
Experience in cross-functional and international environments.

Responsibilities

Lead regulatory strategy development, planning, and execution for product registrations.
Act as liaison with regulatory authorities during audits and submissions.
Monitor evolving requirements and ensure timely implementation.
Represent the organization in regulatory working groups.
Provide regulatory guidance to R&D teams throughout development.
Review development docs for compliance with regs and quality standards.
Drive QMS and lifecycle compliance with GMP and local regs.

Skills

Regulatory affairs

Quality assurance

GMP knowledge

Audit experience

Cross-functional

Education

Bachelor’s Degree in Healthcare Sciences

Advanced degree preferred

Job description

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 RAQA Senior Manager

Job Profile

Manager– Quality & Regulatory– General Quality and Regulatory

Group - Family

Quality– General Quality and Regulatory

Date

May 2026

Grade

Summary

The India RAQA Senior Manager is responsible for leading day-to-day Quality Assurance (QA) and Regulatory Affairs (RA) operations, including R&D regulatory support, to ensure compliance with applicable regulatory requirements and quality standards.

This role drives the development and continuous improvement of Quality Management Systems (QMS), regulatory strategies, and product lifecycle compliance, while partnering with R&D, CDCSO, and cross‑functional teams to enable successful product development, registration, and commercialization.

The position plays a key role in embedding a culture of quality, innovation, and continuous improvement across the organization.

Regulatory Compliance

Essential Duties and Responsibilities

Lead regulatory strategy development, planning, and execution for product registrations, lifecycle management, and compliance activities in India.
Act as the primary liaison with regulatory authorities (e.g., CDCSO) during audits, inspections, and submissions.
Monitor and interpret evolving regulatory requirements and ensure timely implementation.
Represent the organization in industry associations and regulatory working groups where applicable.

R&D Regulatory Support

Provide regulatory guidance to R&D teams throughout product development, ensuring alignment with local regulatory requirements and global strategies.
Review and contribute to design and development documentation, ensuring compliance with regulatory and quality standards.
Ensure regulatory considerations are integrated in the day to day operations, accelerate license approval timelines and minimize compliance risks.

Quality Management System (QMS) Leadership

Establish, implement, and maintain an effective QMS aligned with applicable regulations (e.g., GMP, local regulatory requirements).
Continuously evaluate QMS effectiveness and lead improvement initiatives to enhance compliance and operational efficiency.

Quality Assurance Operations

Oversee QA activities across warehousing, distribution, local labeling, complaints/adverse event handling, and field actions.
Ensure compliance with internal policies and external regulatory requirements, meeting defined KPIs.
Drive consistent execution of quality processes across the product lifecycle.

Risk Management

Lead risk management processes, including risk identification, assessment, mitigation, and monitoring.
Promote a proactive risk-based mindset and quality culture across the organization.

Training And Development

Provide training and guidance to employees on quality -related topics, including regulatory requirements and best practices.

Support the professional development of the quality and regulatory team, fostering a culture of continuous learning and growth.

Cross-Functional Collaboration

Partner with business, supply chain, medical, and commercial teams to integrate quality and regulatory considerations into operations.
Support preparation and review of regulatory submissions, amendments, and compliance documentation.

People Leadership and Development

Lead and develop the RAQA team, fostering a high-performance and compliant culture.
Provide coaching, training, and guidance on regulatory and quality requirements.
Build organizational capability through continuous learning and development initiatives.

Qualifications

Minimum 12+ years of experience in Regulatory Affairs and Quality Assurance within the healthcare or pharmaceutical industry
Strong knowledge of Indian regulatory requirements (e.g., CDCSO, Drugs & Cosmetics Act, GMP)
Proven experience in regulatory submissions, inspections, and compliance oversight
Minimum 5 years of people management experience, with demonstrated success in leading and developing teams
Experience working in cross‑functional and international environments

Education And/or Experience