International Program Regulatory Associate Director (IPRAD)

Roles & Responsibilities:
• Support design and execution of optimal registration strategies for assigned international portfolio
• Drive execution and maintenance of registration plans for INT countries in alignment with global and regional Regulatory Affairs (RA) teams
• Coordinate procurement of ancillary documents and support responses to Health Authority (HA) queries
• Maintain updated databases on country requirements, pipeline information, and registration plans
• Partner with global and regional stakeholders to ensure efficient regulatory pathway planning
• Support Emerging Markets Brands initiatives and registration strategies for INT-focused products
• Collaborate with GRSS&C LCM group on geographic expansion plans
• Disseminate INT country regulatory requirements to global stakeholders and provide education where needed
• Act as deputy to the International Program Regulatory Director (IPRD) when required
• Lead or contribute to regional cross-functional initiatives and committees
• Ensure milestone tracking and timely execution of registration objectives

Qualification:
• Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology or equivalent)
• Advanced degree in Science (Desirable)

Experience:
• Minimum 8 years in Regulatory Affairs or product development
• At least 1 year experience at country, regional, or global regulatory level
• Proven experience in Health Authority negotiations
• Strong project management and cross-functional collaboration experience

Skills:
• Strong understanding of global regulatory frameworks and submission processes
• Strategic thinking and ability to communicate regulatory vision
• Matrix leadership and stakeholder management skills
• Risk assessment and issue resolution expertise
• Organizational awareness and proactive problem-solving
• Ability to travel and represent the organization internationally

About the Organization:
Novartis is a global healthcare leader focused on reimagining medicine to improve and extend people’s lives. The company emphasizes innovation, regulatory excellence, and collaboration while fostering an inclusive culture that reflects the diverse communities it serves worldwide.