Site Delivery Head - Regulatory Services - Life Sciences/Healthcare

Site Delivery Head - Life Sciences/Healthcare Services MNC

Role Overview:

The India Site Delivery Head - Regulatory Services will serve as the strategic and operational leader for operations. The role will be responsible for driving operational excellence, delivery governance, organizational capability building, client success, and scalable growth across both Pharmaceutical and Medical Device Regulatory Services.

The incumbent will lead India operations in close collaboration with global leadership and with strong support from enabling functions, including HR, Finance, PMO, Quality, IT, and Facilities. The role requires balancing strategic business priorities with operational execution while building a high-performing, future-ready organization capable of supporting global client needs.

Key Responsibilities:

1. Strategic &Operational Leadership

2. Digital Transformation & Innovation

3. Quality, Compliance & Governance

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

- Support audit readiness for ISO, client audits, and regulatory inspections

- Strengthen operational risk management and compliance governance practices

- Ensure effective issue resolution, CAPA management, and continuous improvement culture

- Stay updated on evolving global regulatory landscapes and industry best practices

- Desired Competencies: Visionary leadership with ability to scale large delivery teams and build capability depth

- Thought leadership mindset; ability to represent the company externally. Proven experience managing complex regulatory portfolios and global client programs

- Strong understanding of AI/ML adoption in regulatory operations (document automation, intelligence engines, compliance workflows)

- Strong business acumen with experience in proposal development, pricing, and delivery economics

- Ability to build consultative relationships with senior regulatory and quality leaders of global clients

- Demonstrated track record of revenue retention, client satisfaction, and operational efficiency

Educational Qualification:

- Bachelor's degree in Engineering, Life Sciences, Pharmacy, Biotechnology or equivalent (required)

- Master's degree in Regulatory Affairs, Quality Management, MBA (preferred)

- Relevant certifications (e.g., RAC, PMP, Lean Six Sigma, ISO standards) will be an added advantage