Head Regulatory Affairs Strategy Office

Key Responsibilities:

• Together with the Regulatory Affairs (RA) leadership team, defines strategic vision, and objectives by evaluating both the Novartis operating trends, external landscape and new technologies to ensure RA are proactively evolving
• Has oversight of Regulatory Affairs activities required to fulfill current and future drug portfolio commitments and the associated risks. Applies this knowledge to key strategic and operational meetings, acting as an RA Subject Matter Expert (SME) and key point of contact for the Global Head of RA Development
• Connects the dots between RA strategy and what is required to change in short and long term. Provides expert advice and guidance to the Leadership Team, business leaders, and initiative owners, driving prioritization decisions to “stop, start, change” initiatives, ensuring the function is allocating budget and resources in the most important areas. Monitors project timelines, resources, and risks at high-level to ensure successful completion aligned with organizational goals
• Analyses data including Key Performance Indictor (KPI) / metrics to identify Regulatory trends and inform holistic decision making for both Regulatory Affairs and Development. Shares KPIs with key stakeholders to demonstrate RA’s performance and value the function contributes to Novartis and society
• Shapes and mobilizes strategic internal projects with relevant stakeholders, ensuring they are formally initiated, have clear benefit expectations and sufficient governance in place. Ensures the right resources are assigned to set the initiatives up for success. In key projects acts as Steer Co member or leads ad-hoc initiatives where required, driving timelines, managing resources and risks to ensure successful completion aligned with organizational goals
• Works with Strategy Office team to facilitate change management for the Regulatory Affairs function, including the design and execution of comprehensive change management strategies. Ensuring smooth transitions during periods of change, minimizing disruption and driving a connected narrative with broader Novartis Development changes
• Partners with RA Finance to ensure ongoing reporting is correct for Novartis Development Leadership. Provides robust data and leading trends for current year budget and future year planning
• Full member of the RA leadership team and acts as deputy on behalf of Global Head RA
• Acts as a primary liaison with RA line functions, broader Development functions, Biomedical Research and Commercial stakeholders, driving a partnership that enables the best patient outcomes

Essential Requirements:

• Advanced degree or combination Bachelor Degree with equivalent experience
• Minimum of 10 years working in global strategy, innovation or management consulting. Specific experience in Regulatory Affairs is preferred.
• Demonstrates ability to create strategic objectives and plans based on internal and external assessments
• Project management expertise, ideally with strong portfolio management experience
• 5 years of experience in global matrix people management
• Direct people management experience preferred
• Excellent communicator and presenter (oral and written), ability to communicate at all levels
• Ability to recruit key talent and foster culture and environment where associates are working towards their fullest potential

The pay range for this position at commencement of employment is expected to be between $245,600 and $368,400 /year; however, while salary ranges are effective from 1/1/24 through 12/31/2024, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity & Inclusion: The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.