Global Program Regulatory Manager

Global Program Regulatory Manager

Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people’s lives. We are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic area and platform depth and capabilities – all to bring our medicines to patients even faster. We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to.

The Role

This role offers hybrid working, requiring 3 days a week / 12 days a month based in the office. As a Global Program Regulatory Manager, you will work with the support of a RA Program Lead to develop and implement the global regulatory strategy for program(s) through development, registration, and post approval in the assigned region(s). The Global Program Regulatory Manager is also a member of the RA sub-team and may lead or represent RA in regional or cross-functional teams.

Major Accountabilities

Regulatory Strategy

• Provide input to the global program regulatory strategy, including regulatory designations and innovative approaches.
• Coordinate regulatory readiness with other line functions, Country Organizations & Regions, representing RA or leading in regional RA or cross-functional activities.
• Contribute to the development and maintenance of key documents, determine the requirements, and coordinate the activity for HA interactions.

Regulatory Submissions

• Lead planning, preparation, and submission of clinical trials.
• Lead implementation of the defined global registration strategy into regional submissions worldwide by country organizations.
• Coordinate, plan, and prepare for submission of initial registrations and post approval applications, and the preparation, review, and maintenance of local product information as assigned.
• Lead regulatory activities during HA reviews, responding to questions and HA interactions.

Regulatory Excellence & Compliance

• Ensure timely RA input and submission of regulatory compliance and maintenance reports, maintaining regulatory information in compliance databases and document management systems.

Your Experience

• Science-based bachelor's degree, plus an understanding of pharmaceutical development and clinical trials.
• Track record of involvement in regulatory or pharmaceutical development, in one or more major regions.
• Strong interpersonal skills and experience working in a complex, cross-functional organization and leading cross-functional teams.
• Compliance and Quality mindset.
• Fluency in English.

Why Novartis

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting, and inspiring each other. Combining to achieve breakthroughs that change patients’ lives.

Commitment to Diversity & Inclusion

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.