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.

The GPRM works with some independence under limited supervision to provide strategic and operational regulatory direction and may support the RA global program team (GPT) representative and/or GTAL for programs through development, registration and approval/post approval. The GPRM ensures the execution of regulatory plans in line with global regulatory strategy in close collaboration with the RA GPT representative and/or GTAL. In certain cases, the GPRM may act as the GPT representative. The GPRM is a member of the RA sub team and may indirectly report to the RA GPT representative for the project and may have responsibility for leading regional RA sub teams.

Your responsibilities include, but are limited to:

• Provide input into regulatory strategies and take responsibility for their subsequent implementation
• Manage operational activities for assigned projects and regions in accordance with applicable regulatory standards and within appropriate timeframes
• Represent Regulatory Affairs and lead sub-teams and/or cross-functional teams as required
• Lead or coordinate Health Authority meetings in assigned region(s)
• Contribute to the development of global and local labelling and review of promotional and non-promotional material in assigned region(s)
• Contribute to regulatory excellence by finding opportunities, mitigating risks and supporting continuous optimization and simplification
• Handle internal systems and tools that are needed to assess compliance

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.

What you'll bring to the role:

• Science Based BSc or MSc. Advanced degree (MD, PhD, PharmD) preferred.

• Experience with regulatory submission and approval processes in 1 or more major regions, as well as experience in a global/matrix environment or cross- functional teams in the pharmaceutical industry, and in Health Authority negotiations

• 2-4 years involvement in regulatory and drug/biologic development spanning activities in Phases I-IV in the following areas: innovation in regulatory strategy; involvement in a dossier submissions and approvals; Health Authority negotiations; drug regulatory submission and commercialization in region; analysis and interpretation efficacy and safety data; understanding of post-marketing/brand optimization strategies and commercial awareness; regulatory operational expertise

• Strong interpersonal, communication, negotiation and problem solving skills

• Basic organizational awareness (e.g., interrelationship of departments, business priorities)

Why consider Novartis?

736 million lives were touched by Novartis medicines in 2022, 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.

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 tas.nacomms@novartis.com 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-us-job-openings

The pay range for this position at commencement of employment is expected to be between $118,400 and $177,600/year; however, while salary ranges are effective from 1/1/23 through 12/31/23, 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

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Global Drug Development

REG AFFAIRS GDD

USA

Cambridge, MA

Novartis Pharmaceuticals

Research & Development

Full Time

Regular

No

No