Global Program Regulatory Manager (
- East Hanover, New Jersey, United States
- Closing date
- Mar 23, 2023
- Other, Legal/Regulatory Affairs
- Position Type
- Full Time
- Job Type
- Organization Type
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
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.
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. That’s how many lives our products touched in 2022. 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.
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.
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 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.
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 send an e-mail to [email protected] or 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.
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
At Novartis, we are reimagining medicine.
Our purpose is to reimagine medicine to improve and extend people's lives. We use innovative science and technology to address some of society's most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible.
Novartis has one of the industry’s most competitive pipelines. Many of these projects, which include new molecular entities as well as additional indications and different formulations for marketed products, are for medicines that could significantly advance treatment standards for patients worldwide.
We have entered an exciting era in health and biomedical innovation. Powered by our incredible colleagues, supported by our flexible-hybrid working model, new AI powered learning, personal growth and career platform and a refreshed commitment to diversity, equity & inclusion, we are well-poised to help lead this transformative moment for our industry and for ourselves. Join Us!
Get job alerts
Create a job alert and receive personalized job recommendations straight to your inbox.Create alert