Apr 21, 2022

Job Description

1,800+ associates. 86 countries. One Regulatory Affairs. At Novartis your voice, experience, and quality mindset can truly make a difference in Regulatory Affairs (RA). Novartis has a unique and promising portfolio with 70 projects as potential NMEs in development, 65 projects in Phase 3 or already undergoing registration, and 100 Phase 1/2 projects. We also focus on rare disease areas; in fact, more than 80% of our innovation is targeted on areas of high unmet need. In many cases, we can offer family friendly work flexibility to facilitate your physical and mental health. Read on to learn about the role available in Regulatory Affairs. We hope you will consider joining our global OneRA family.

Job Purpose
Regulatory policy and intelligence leader who directs a regional team in developing and implementing complex regulatory strategies and product advocacy in global development to achieve Novartis enterprise objectives and enable regulatory compliance.

Major Accountabilities
• Develop high quality and globally aligned regulatory policy strategies to facilitate optimal development objectives and lifecycle management plans
• Serves as regulatory policy expert and/or lead of cross-functional teams responsible for proactively monitoring and responding to emerging scientific trends/strategies
• Actively shape and influence changes impacting Novartis enterprise and biopharmaceutical industry in the regulatory environment including laws, regulations, and guidances
• Participate and/or lead trade association committees, external working groups and/or represent Novartis in advocacy groups impacting our strategic priorities
• Analyze impact and anticipate implication of important emerging regulatory requirements and political environment on Novartis business, communicate new and emerging regulatory requirements
• Provide strategic advice on policy issues across therapeutic areas within the RA DUs and with sub-region heads.
• Manage and coach team members and contribute to their individual development within Regulatory & Development Policy team
• Effective matrix management of regulatory policy team(s) consisting of other RA and GDD line functions, providing, to the extent possible, mentorship and opportunities for growth and development.

Diversity & Inclusion / EEO

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

Minimum Requirements

What you'll bring to the role:
• Minimum 8-10 years of regulatory and drug/biologic development experience, Health Authority experience desirable.
• Fluency in English as a business language. Additional language is an asset
• Science-based, health policy or legal studies BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) desirable.
• Minimum 5 years or more people management experience required; this may include management in a matrix environment.
• Demonstrable history of success over multiple years in a regulatory or health policy role with a strong understanding of regulatory and legislative environment, and the drug development processes
• Organizational awareness (e.g., interrelationship of departments, business priorities), including experience working cross functionally and in global teams.
• A flexible, positive and creative thinker with the proven ability to develop and implement innovative policy strategies and processes
• Strong interpersonal, communication, negotiation and problem-solving skills.

Why consider Novartis?

799 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

Imagine what you could do at Novartis!

Join our Novartis Network:

If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:

Global Drug Development
United Kingdom
Research & Development
Full Time
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Regional Head RA EU Policy & Liaison

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