Senior Global Program Regulatory Manager (Cardio-Renal-Metabolism)

　　Job ID

　　390570BR

　　Jan 22, 2024

　　USA

　　About the Role

　　#LI-Hybrid; #LI-Onsite

　　On-site Hybrid

　　1,800+ associates. 85+ countries. 1 goal. At Novartis, we are dedicated to discovering and developing new treatments for diseases including cancer, heart disease, and neurological conditions—and delivering them at a scale to reach as many patients as possible. Novartis has a unique and promising portfolio with approximately 70 projects as potential NMEs in development, 52 projects in Phase 3 or already undergoing registration, and 100 Phase 1/2 projects. And you could be at the center of it all in Regulatory Affairs (RA), where your voice, experience, and quality mindset can truly make a difference in drug development at Novartis. Read on to learn about the role available in RA. We hope you will consider joining our global RA family.

　　The Sr Global Program Regulatory Manager will work independently under limited supervision to provide strategic and operational regulatory direction and may support the Regulatory Affairs Global Program Team (GPT) representative and/or Global Therapeutic Area Lead (GTAL) for programs through development, registration and approval/post approval. The Sr GPRM ensures the execution of regulatory plans in line with global regulatory strategy in close collaboration with the RA global program team (GPT) representative and/or GTAL. In certain cases, the GPRM may be the GPT representative. The Sr GPRM is a member of the RA sub team and may indirectly report to the RA GPT representative for the project and has responsibility for leading regional RA sub teams.

　　Your Key Responsibilities:

　　• Provide input into global regulatory strategies and implement in assigned regions (focus US/LaCan) in collaboration with local teams

　　• Act as FDA liaison for assigned products

　　• Represent Regulatory Affairs and lead regulatory and cross-functional sub-teams

　　• Lead or coordinate Health Authority meetings

　　• Contribute to the development of global and local labeling and review of promotional and non-promotional material

　　• Ensure regulatory compliance, e.g. keep records of relevant Health Authority interactions in document management system and compliance databases

　　Diversity & Inclusion / EEO

　　We 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.

　　Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:

　　Novartis: e-mail [email protected] or call +1 (877)395-2339

　　Sandoz: e-mail [email protected] or call: +1-609-422-4098

　　Role Requirements

　　• Science based BS or MS. Advanced degree (MD, Ph D, PharmD) preferred

　　• Prior experience in oligonucleotide or RNAi therapies preferred

　　• 4-6 years involvement in regulatory and drug/biologic development spanning activities in Phases I-IV, including experience in leading regulatory submissions and approvals in at least 1 major region

　　• Experience in a global/matrix environment or cross functional teams in the pharmaceutical industry

　　• Strong interpersonal, communication, negotiation and problem solving skills

　　• Proven ability to analyze and interpret efficacy and safety data

　　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: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards .

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

　　Compensation and Benefits Summary: The pay range for this position at commencement of employment is expected to be between $174,400 and $261,600/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, 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.

　　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

　　Division

　　Development

　　Business Unit

　　REG AFFAIRS GDD

　　Location

　　USA

　　Site

　　East Hanover, NJ

　　Company / Legal Entity

　　Novartis Pharmaceuticals

　　Functional Area

　　Research & Development

　　Job Type

　　Full Time

　　Employment Type

　　Regular

　　Shift Work

　　No