We are looking for a seasoned and strategic leader to head India operations for a global Regulatory Services business supporting Pharmaceutical, Medical Device, IVD, and Combination Product industries. This leadership role will be responsible for driving business growth, operational excellence, delivery governance, capability building, client partnerships, and digital transformation initiatives across the India business.

The incumbent will work closely with global leadership teams and cross-functional stakeholders to build scalable operations, strengthen delivery maturity, enhance customer experience, and drive future-ready transformation initiatives.

Key Responsibilities:

Strategic & Operational Leadership

- Lead end-to-end India operations for Regulatory Services across Pharma and Medical Device verticals

- Define and execute business strategy aligned with global goals and growth priorities

- Establish governance frameworks, KPIs, operational metrics, and performance standards

- Drive operational efficiency, utilization improvement, resource optimization, and margin enhancement

- Partner with HR, Finance, PMO, Quality, IT, and support teams for seamless execution

- Build a high-performance, accountability-driven organization culture

Delivery Leadership Regulatory Services

- Oversee global regulatory programs across Pharmaceutical, Medical Device, and IVD domains

- Ensure quality delivery, regulatory compliance, and customer satisfaction across engagements

- Strengthen governance mechanisms, escalation management, and risk mitigation processes

- Lead process optimization and standardization initiatives across delivery functions

Client & Business Partnership

- Act as strategic advisor and relationship leader for global clients and key accounts

- Build strong partnerships with senior stakeholders across Regulatory, Quality, and Compliance functions

- Support account growth, client retention, and expansion opportunities

- Collaborate with business teams on solution design, proposals, effort estimations, and commercial discussions

- Contribute to capability expansion and strategic growth programs

Capability Building & Talent Leadership

- Build and scale multidisciplinary teams across Pharma and Medical Device Regulatory domains

- Drive succession planning, leadership development, and capability enhancement programs

- Strengthen expertise in regulatory operations, project delivery, client management, and leadership effectiveness

- Foster an inclusive, collaborative, and innovation-led environment

- Lead employee engagement and retention initiatives

Digital Transformation & Innovation

- Drive adoption of AI-enabled regulatory tools and automation frameworks

- Identify opportunities for productivity enhancement and process automation

- Promote digital transformation initiatives across regulatory workflows, compliance tracking, and document management systems

- Support implementation of technology-led operating models and future-state delivery frameworks

Quality, Compliance & Governance

- Ensure adherence to global regulatory standards, internal SOPs, and quality systems

- Support audit readiness, compliance reviews, and inspection requirements

- Strengthen operational risk management and governance practices

- Drive CAPA implementation and continuous improvement initiatives

Industry Leadership & External Engagement

- Represent the organization at industry forums, conferences, and leadership platforms

- Contribute to thought leadership in Regulatory Affairs, AI-enabled operations, and transformation programs

- Stay updated on evolving global regulations and industry trends

Desired Profile:

- 20+ years of experience in Regulatory Services, CRO, Pharma, Medical Devices, IVD, Regulatory Consulting, or related industries

- Proven experience leading large-scale delivery operations and global client programs

- Strong exposure to Pharma Regulatory Affairs and Medical Device / IVD regulatory environments

- Experience in scaling teams, capability development, and delivery governance

- Strong commercial acumen with exposure to proposal development, pricing, margins, and delivery economics

- Understanding of AI/ML applications, automation, and digital transformation in regulatory operations

- Excellent executive communication, stakeholder management, and influencing skills

- Demonstrated success in client retention, operational excellence, and business growth

Education:

- Bachelors degree in Engineering / Life Sciences / Pharmacy / Biotechnology or related disciplines

- Masters degree in Regulatory Affairs / Quality Management / MBA preferred

- Certifications such as RAC, PMP, Lean Six Sigma, ISO, or equivalent will be an added advantage

Ideal Background:

Candidates currently working in:

CRO | Regulatory Consulting | Pharma Services | Medical Devices | IVD | Regulatory Operations | Global Delivery Centers | Compliance & Quality Organizations

Location: Bangalore

Experience Range: 20-30 Years

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