Executive Director, Regulatory Operations
Executive Director, Regulatory Operations
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Job Description
Job Description Summary
#LI-Hybrid (12 days per month on-site)Location: London (The Westworks) United Kingdom
Internal Job Title: Head of Regulatory Operations
As a pivotal senior leadership role within the Regulatory Affairs (RA) and Enabling Functions (EF) organization the Head of Regulatory Operations will lead the strategic direction and execution of Novartis global Regulatory Operations capabilities. This includes submission management document standards publishing structured data submissions and submission intelligence. You will be at the helm of planning tracking and managing the regulatory lifecycle for our diverse global portfolio ensuring seamless delivery and compliance across markets. This is a unique opportunity to drive innovation operational excellence and strategic impact at scale.
Job Description
Key responsibilities:
Global Leadership & Organizational Excellence: Establish and evolve a best-in-class Regulatory Operations (RO) organization driving performance accountability and a culture of continuous improvement.
Strategic Submission Oversight: Approve and guide strategies to elevate the quality and efficiency of Development registration dossiers including NDAs MAAs and major supplements/variations.
Patient-Centric Impact: Champion submission plans that promote execution excellence maximize content re-use and enable simultaneous health authority reviewsadvancing global patient equity.
Portfolio Accountability: Align teams with business frameworks to ensure clear ownership and continuity across submission management activities.
Digital Transformation & Innovation: Spearhead automation and digitalization initiatives ensuring RO technologies are business-aligned well-supported and future-ready.
Health Authority Engagement: Lead direct interactions with global Health Authorities to negotiate e-submission strategies and resolve validation issues ensuring successful application acceptance.
Industry Leadership & Future-Fit Models: Monitor regulatory trends and implement innovative operating models that position Novartis at the forefront of regulatory excellence.
External Influence & Advocacy: Represent Novartis in Health Authority forums and industry working groups shaping evolving regulatory guidelines and submission strategies.
Global Standards & Compliance: Define and implement harmonized global standards and processes to ensure consistent regulatory submission compliance across markets.
Essential Requirements:
Industry Expertise: Extensive experience in the pharmaceutical industry with a strong background in global Regulatory Operations or equivalent functions.
Strategic Leadership: Demonstrated success in guiding large geographically dispersed teams providing clear strategic direction and fostering a high-performance culture.
Global Submission Mastery: Proven track record of leading high-priority initial applications and executing rapid globalization strategies within a major pharmaceutical organization.
End-to-End Drug Development Knowledge: Deep understanding of the drug development lifecycle pharmaceutical business dynamics and strategic portfolio management.
Executive Presence: Senior leadership experience with exceptional communication negotiation and stakeholder engagement skills including representation at Executive Committees.
People Leadership: Strong capability in managing mentoring and developing talent with a focus on building resilient empowered teams.
Innovative Mindset: A creative and forward-thinking approach to problem-solving with a passion for driving continuous improvement and innovation.
Results Orientation: A proactive transparent and accountable working style with the ability to deliver under pressure and navigate complexity with confidence.
Commitment to Diversity and Inclusion/EEO
Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve.
Skills Desired
Cross-Functional Teams Drug Development Global Clinical Trials Lifesciences Negotiation Skills People Management Problem Solving Skills Program Management Regulatory Compliance Risk Management StrategyRequired Experience:
Director
Employment Type
Full-Time
