347415BR
Jun 22, 2022
USA

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.

Facilitate application of regional regulatory requirements and intelligence to provide strategic direction and product advocacy in global development to achieve Regulatory Affairs enterprise objectives and enable regulatory compliance

You're responsibilities include, but are not limited to:

• Provide regular communications and briefings to Global and Regional Policy Heads on relevant global regulatory policy issues
• Participate in internal product team meetings to provide regulatory policy context for business decisions
• Provide strategic regulatory advice to RA colleagues on drug development projects and registration, and marketed products in preparation for HA meetings.
• Develop training materials and participate as a facility member on new and emerging regulatory requirements for RA colleagues and other line functions
• Analyze impact of important emerging regulatory policies and new requirements on Novartis projects and business.
• Prepare and coordinate internal customer feedback on proposed laws, regulations and guidances, to ensure consideration of Novartis positions by trade organizations
• Represent Novartis on external committees e.g. trade associations
• Collaborate with Novartis Corporate Affairs to shape emerging legislative proposals

Diversity & Inclusion / EEO

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.

Minimum Requirements

What you'll bring to the role:

• Education: Science-based, health policy or legal studies BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD)

• Minimum 6-8 years of regulatory and drug/biologic development experience, Health Authority experience desirable

• Demonstrable history of success over multiple years in a regulatory or health policy role with a strong understanding of regulatory and legislative environment

• Command of the drug development process, pharmaceutical business

• Knowledge and experience with local regulatory affairs and regulations

• Organizational awareness (e.g., interrelationship of departments, business priorities), including experience working cross functionally and in global teams.

• Ability to enable teams to think strategically, creatively and proactively

• A flexible, positive and creative thinker with the proven ability to develop and implement innovative policy strategies and processes

• Good management, interpersonal, communication (both verbal and written), negotiation and problem solving skills

Why consider Novartis?

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!

Commitment to Diversity & Inclusion:

Novartis embraces diversity, equal opportunity and inclusion. 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.

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: https://talentnetwork.novartis.com/network

Accessibility and reasonable accommodations:

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

https://www.novartis.com/careers/careers-research/notice-all-applicants…
Global Drug Development
REG AFFAIRS GDD
USA
East Hanover, NJ
Research & Development
Full Time
Regular
No
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347415BR

Director, Regulatory Policy & Intelligence

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