International Program Regulatory Director (IPRD)
Job ID: REQ-10056370
Location: Hyderabad, India
Division: Development
Business Unit: Universal Hierarchy Node
Employment Type: Full-time, Regular
Shift: No
Summary
The International Program Regulatory Director (IPRD) provides strategic oversight and support to global and regional teams for the design and execution of optimal registration strategies and plans for assigned portfolios in International (INT) countries (excluding China, Japan, and the European Union).
By partnering with global Drug Unit (DU) line functions (LF) and INT cross-functional stakeholders, the IPRD ensures timely registration plan design, alignment, and execution. The role maintains country-specific requirements, pipeline information, and registration plans, while leading initiatives to enhance efficiency and functional excellence.
The IPRD is part of the global RA subteam, leads the INT RA subteam for assigned countries, and may act as deputy to the Regulatory Head for Pipeline Management, Compliance, and Operations.
Key Responsibilities
Team Leadership & Management
Set up and manage the INT RA subteam, including global and country RA roles.
Lead the generation of optimal registration strategies and ensure their inclusion in global plans.
Represent INT countries at the global RA subteam level.
Mentor International Program Regulatory Managers and Sr. Managers on pipeline management and RA best practices.
Participate in recruitment, growth, and development of IPRM/D associates.
Registration Strategy & Planning
Drive registration plan design, alignment, and sign-off with relevant regulatory, commercial, and DU stakeholders.
Disseminate agreed registration plans to relevant global and INT stakeholders.
Maintain up-to-date registration plans, supporting documentation, and milestone tracking.
Collaborate with DU RA roles (GPRDs, GRTLs) for pipeline overviews and operational planning.
Support registration of products targeting diseases predominantly prevalent in INT countries.
Regulatory Compliance & Policy Management
Monitor emerging regulatory policies and requirements across INT countries.
Translate new requirements into actionable plans for project execution.
Maintain country requirement repositories and ensure information dissemination.
Partner with RA INT roles and global policy teams for shaping regulatory policies in INT countries.
Functional Excellence & Initiatives
Lead initiatives to improve efficiency and ways of working within RA INT.
Serve as main contact for Emerging Markets Brand registration plans and Center of Excellence activities.
Represent INT RA in functional or cross-functional initiatives impacting resources or FTE allocations.
Stakeholder Engagement
Oversee responses to Health Authority (HA) questions and ensure timely follow-up on key milestones.
Maintain up-to-date contact lists for programs and country offices (COs).
Provide education and information on INT regulatory requirements to global teams.
Minimum Requirements
Experience: Minimum 8 years in Regulatory or Product Development, including at least 2 years at country, regional, or global Regulatory level.
Skills:
Proven experience in Health Authority negotiations.
Strategic vision development and communication.
Cross-functional collaboration and project management.
Strong leadership and team-oriented mindset.
Risk assessment and regulatory issue resolution.
Education: Science-based BS or MS required; advanced degree (MD, PhD, PharmD) preferred.
Travel: Ability to travel and represent the organization.
Commitment to Diversity and Inclusion
Novartis is dedicated to building an inclusive environment and diverse teams that reflect the patients and communities served.
Accessibility & Accommodation
Reasonable accommodations are available for individuals with disabilities during recruitment or to perform essential job functions. Contact: diversityandincl.india@novartis.com with job requisition number and accommodation request details.
Why Novartis?
Novartis fosters collaboration, innovation, and inspiration to help patients and families. Join a community working together to achieve breakthroughs that improve lives.
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